Pfizer

CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.

No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue

Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone

Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on right side after one week of injection. Bilateral swelling of lymph nodes by day nine.

Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.

Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.

Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration

Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was "102 something", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.

I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case

I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.

12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.

About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.

Following vaccination, patient reported throat scratchiness in the right side. She has had previous allergic reactions to allergy shot and stated that this is how she felt before. VS: 0740- HR 127, O2 100%, BP 127/75. 0752- HR 100, O2 100%, BP 134/82. 0805- HR 103,O2 100%, BP 159/80. Patient evaluated by physician and monitored in clinic for additional 30 minutes. 0841 HR 104 O2 98 BP 135/77; 0847 HR 100 O2 100 BP 136/73. Discharged from clinic. On 1/4/21 patient presented to urgent care reporting that over the course of the evening and next day she developed intermittent fevers with a T-max of 103 degrees as well as headache and lightheadedness. She has had intermittent symptoms ongoing since her vaccination prompting her to come for evaluation at urgent care. She denies difficulty swallowing. She had been intermittently taking antihistamines. Positive for sore throat. COVID antigen testing was negative, patient discharged.

Headache; Fatigue; Muscle/ joint pain; Muscle/ joint pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) Intramuscularly on 26Dec2020 10:30 AM (Anatomical Location: Arm Left) at single dose (first dose) for COVID-19 immunization. Medical history and concomitant medications were reported none. Patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Headache, Fatigue, Muscle/ joint pain on 26Dec2020 12:30 PM. Patient did not receive any treatment. The outcome of the events was recovered in unknown date. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.

Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2

One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.

Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.

eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.

Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and developed a fever of 101.

I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience severe fatigue. At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4. Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20. No other symptoms to report besides a tender injection site for the first 48 hours.

I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.

Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day one. Headache. Arm pain out of proportion to previous IM vaccinations.

Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.

Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.

Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep was very sore. I have regular yearly flu shots with no issues.

dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.

After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.

Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had covid March 2020.

Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and muscle aches. Took 600mg ibuprofen. At 1am had massive headache body aches chills to the core. Took more Tylenol. At 5:30am fever of 100.4 and flu like symptoms. Called into work.

I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a slight sore throat. I left work early at that time. When I got home I couldn't stay awake and fell asleep around 6pm. Then starting having GI distress cramping, pain and diarrhea around 9pm-11pm. At 2 am I woke up with chills and fever, I took a Tylenol around 3-4 m and then broke out if huge sweat, then finally fell asleep. 1/7/21 I mostly have soreness, headache and fatigue now.

I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.

On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone

Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately 48 hours of COVID like symptoms, similar but milder than what they experienced with the infection. Noted extreme fatigue, pain, diarrhea, chills and muscle aches with resolved after approximately 48 hours.

Sensitive to temperature, chills , fever, sweats, headache, tx with tylenol, with no relief, 01/07/2021 faint headache only

Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.

12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature 100-101, nasal congestion, and profound fatigue. Symptoms resolved after 36 hours with Tylenol/Advil and supportive care. Sent for COVID Rapid PCR which was negative; missed 1 day of work.

Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness

After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.

Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.

Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.

Fatigue; fever; chills; body aches; headache; This is spontaneous report from a contactable other hcp (patient). A 40-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 29Dec2020 11:45 at single dose for COVID-19 immunization. Medical history included anxiety/depression-mild, known allergies to penicillin (PCN), patient was diagnosis (dx) with Covid 19 on 20Nov2020. Concomitant medication included duloxetine, hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZID), colecalciferol (VITAMIN D), paracetamol (TYLENOL) and MV, all received within 2 weeks of vaccination. The patient experienced fatigue, fever, chills, body aches, headache that lasted about 24 hours, all started from 29Dec2020 11:45. Then continued fatigue and mild body aches since then. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.

Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days

Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours

I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time walking around the hospital I almost fell asleep on my desk. I fell asleep that night and felt fine the next day! Advanced maternal age because I'm 40 so I'm high risk, Low on Vitamin D3 early in my pregnancy, beginning of Dec I was lightly anemic, due date Feb 9th

Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.

Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.

Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.

Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite

Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic

bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.

fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil at 230 pm and tylenol at 330 pm on 01/08/2021. Pt. states that she is feeling much better after tylenol.

fever 103, chills, achy body. Fever broke 2nd of January. Headache beginning on the 5th ended on the 7th that may or may not be related.

low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)

1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.

11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL

Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Body and head aches, particularly joints and back, continue and have worsened at 30 hours out. Mild-mod soreness at injection site (4/10)

11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain

12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started and lasted for 12 more hours. Conservative management at home with oral fluid hydration, acetaminophen and ibuprofen helped improved symptoms. Headache is still present on 1/10 at 0200 am, over 24 hr after injection.

Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.

I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl

Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.

headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA

0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal

About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hours post vaccine developed rash - raised red swollen area around where the vaccine was given. The area was hot to the touch and very itchy. Currently great than 72 hours post vaccine and rash is still there and still hot and itchy.

Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 days. Visited urgent care 1/2/21 - labs done & released w/ return to work 2-5 days.

Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,

Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for another 24 hours. Joint pain, headache and low grade fever for 48 hours.

Started out with my shoulder blades being sore that night. I woke up the next morning and was sore all over, my head hurt, and my temperature was anywhere from 100.3-101. I checked it various times thru out the day. By the time I was ready for bed I felt a little better, but not up to normal standards. I slept thru the night and woke up fine. I wasn't sore anymore and my twmp was 98.2.

The day after the injection she noticed swelling in her right axilla that is painful but no redness. She also had one day of headache, chills and joint pain.

This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.

Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.

fatigue was about 6 hours post vaccination, 12 hours after vaccination + fatigue, Headache, muscle and joint pain/aches and chills, ibuprofen taken and resolved HA. 24-30 hours post vaccination + severe body aches (bone pain) and chills. All symptoms resolved at 30 hours post vaccination

Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, severe body aches, chills, and lethargy

Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.

Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.

Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number is requested.

Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face and it was affecting vision a little. Called them and they told me to come back. I felt light headed and they put me in the wheelchair and took me to ER. ER: assessed by Dr: heart monitor for 30 minutes. Sent me home to watch my symptoms. Numbness in my face lasted into next day but then went away after that. Still having dizziness on and off since I've received the shot. Headaches - having them, too, off and on. TeleMed appt with DR on 7th. She recommended a MRI of brain - normal.

Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, warmth, pain at injection site.

Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site

Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."

about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Fever, Headache. Stated that a few hours later she started with diarrhea

severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.

swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic

Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient developed diarrhea which lasted 2 days. She was covid tested 1/9/2021 which was negative.

I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was initially some mild tingling in extremities. After an hour later, my legs were almost numb and I had difficulty moving them. The fatigue got increasingly worse

Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose

This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.

about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms resolved 48 hours post injection but had upset stomach and loose stool which persisted. 1st injection just had soreness at site and a mild headache

drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination

lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. These symptoms lingered into the next day causing me to stay home from work the following day.

Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.

Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.

Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen after vaccine given. No problem until following day, late morning. Ibuprofen and tylenol alternating. Swelling and redness at injection site have increased daily.

Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would pop up on hands and elbows, and right foot that would itch and come and go, but the bumps on the left leg wont go away. I have taken benadryl (2 adult tablets each night), hydrocortisone cream, alcohol rub, and still hasn't gone away a week later. Headache for 7 days. A little dizziness.

Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs

Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight nausea

Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.

Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89

Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium

developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved upon arrival to ED. no further intervention. - observed for 4 hrs, d/c to home

fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient experienced fatigue with outcome of recovering. The patient did not receive any treatment for the event. The event was assessed as non-serious. No follow-up attempts are possible, information about batch number cannot be obtained.

onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.

uncontrolled chills that lasted for an hour; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number E5168/expiration date unknown), dose number 2 intramuscularly on 07Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The vaccine was administered in a Public Health Clinic facility. No other vaccine was received within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. Medical history included diabetic and high blood pressure. Historical vaccine included dose 1 of BNT162B2 (lot number EK5730) on 17Dec2020 for immunisation. Concomitant medications included unspecified routine diabetic care meds. On 08Jan2021 03:50, the patient experienced uncontrolled chills that lasted for an hour. She received 2 Advil liquid gels for the event. The outcome of the event was Recovered/Resolved With Sequel. The event was assessed as non-serious.

1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response

Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.

Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-contactable nurse. A 40-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 12:00 to 28Dec2020 12:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took chlorhexidine and experienced allergies. The patient experienced Fever to 99.8 body, muscle aches, Headache and sore arm for days, felt like being punched repeatedly in the arm; all on 28Dec2020. The outcome of the event was recovered on unspecified dates. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums the next day. Outcome complete resolution of symptoms on day 3.

Headache, Acetaminophen and rest, 24+ hours Nausea, no treatment, 24+ hours Fatigue, rest, 24+ hours Chills, blanket, intermittent over 24+ hours

Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.

I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.

Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.

muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, intramuscular right arm from 08Jan2021 to 08Jan2021 as single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2 via intramuscular from 18Dec2020 to 18Dec2020 with lot number: EJ1685 on right arm. Medical history included allergies to sulfa drugs. Concomitant medication included metronidazole. The patient previously took Ciprofloxacin and Codeine and experienced allergies. On Saturday, 09Jan2021 at 07:00 AM, the patient developed fever, muscle aches, nausea, and vomiting. The outcome of the events was recovered on Jan2021. No treatment was given for the events. No follow-up attempts are possible. No further information is expected.

within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches

1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 hours (8pm) I developed pain and swelling in my left armpit. I went to bed and woke up with the same swelling and pain. Checked in at Urgent Care 1/15/20 swelling started in glands in neck around mid day.

My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless I touch it, but if I do bump it or make contact with it, it hurt like the area was very bruised or recently injured. The pain has improved but it is still very sensitive. I didn?t think it was related to the shot, but I could not recall any injury. I can function like normal. My dr suggested I do a round of steroids, but to contact her immediately or go to ER if it worsened. I am to follow up with her in 2 weeks.

Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.

Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for a little bit. Woke up to eat around 6pm on 1/13/21 and started to get chills and not feeling well along with the headache and fatigue so decided to lie back down. Woke up 1:30am on 1/14/2021 soaked in sweat and nauseous still having all the other symptoms. Took oral temp and was 101.4 shortly after vomited and started having some body aches and went back to bed. Woke back up 5am on 1/14/2021 fever had broke, still had headache, fatigue, and some chills and went to work, took imitrex to help with headache. 1/15/2021 woke up at 4:30am with slight headache feeling much better and by 1/16/21 most symptoms have subsided or gotten extremely better.

1/7/2021 - NAUSEA, LEG PAIN, CHILLS, FEVER (100); 1/8/2021 - CHEST TIGHTNESS; VA HOSPITAL ED @3PM. GOT AN EKG, XRAY, BLOOD TEST. FEVER UNTIL 8PM (101 F); BODY ACHES.

102 F fever through 1 gram acetaminophen (104.6 prior to medication), extreme body aches and headache, overwhelming fatigie, and diapohretic x 2days. Swelling of arm from elbow to axilla during same. Unable to work during symptoms. Moderate fatigue, body aches, headache, and site tenderness persist to date of reporting.

Hypotension, tachycardia, dizziness, nausea, vomiting (intermittent x 4 days), left arm pain, joint pain, chills, low grade temperature, diaphoresis, lethargy confusion (day 1 only) headache- symptoms last 4 days with height at 24-48 hours

Patient stated she had chest heaviness and SOB the evening after receiving the vaccine. She saw her PCP and got a steroid shot and took Benadryl on 1/15. On 1/17 she came to the ER with complaints of cough and chest heaviness thought to be caused by the vaccine. She was treated for underlying pneumonia with azithromycin 500mg PO, cefdinir 300mg PO, and a one time dose of methylprednisolone 125mg IM.

Received dose 1 of vaccine and on day of and day after of vaccine administration experienced headache, chills, fatigue. and body aches--all flu like symptoms pregnancy info not avl from report filed.

Starting the evening January 14th I experienced a high fever of 102.3 which responded to Tylenol however, was persistent for 48hours; in conjunction I experienced significant body aches, migraines, diarrhea, chills, and fatigue. Fever broke by Sunday morning however continuance of body aches and fatigue lasted through the weekend.

severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5 c; This is a spontaneous report from a contactable Physician .This Physician reported different events for 2 doses. This case is for 2nd dose. The 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on 08Jan2021 at SINGLE DOSE for COVID-19 immunization. She received the first dose on 17Dec2020 8:00 AM at right arm at single dose Lot number#Ej1685 and she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain.Medical history included Possible asthma and left foot post traumatic arthritis with multiple surgeries including precious allograph, meralgia parasthetica left side. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None Concomitant medications (received within 2 weeks of vaccination) .No known allergies. . After second vaccine severe aching hands, feet like arthritis bad day after vaccine. Low grade fever 99.5 c. No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering on unspecified date. Information on lot/batch number has been requested.

3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are needed. No further information is expected.

During the Covid vaccine observation period the patient complained of hoarseness, itching and throat swelling. The patient had history of chronic urticaria and prior to receiving her vaccine had taken benadryl, ranitidine as well as an OTC antihistamine at home. She was escorted via wheelchair to the ED, BP 151/102 and pulse 101 in ED, pt noted to have blanching hive-like rash on her chest as well. Received Epinephrine 0.3mg, prednisone 60mg PO x 1. Pt was monitored for 3 hours and discharged to home.

I had two am Jan 9, chills, aches, low grade temperature. That lasted about 24 hours. Malaise - extreme -lasted the same amount of time. I took Tylenol twice.

I woke up at 2am (about 12 hrs after vaccine) with fever and sweats. Took acetaminophen and went back to bed. Up at 6am feeling very fatigued and exhausted. Fever again. Got a shower but couldn't stand up that long too exhausted, dizzy and naseau. Went back to bed and called in sick to work. Took IBU 800mg. Back to sleep. Up at 9m more Tylenol. This continued all day trying to keep fever down. 48hrs later still taking acetaminophen to manage symptoms (back to work) still feeling tried and low grade fever.

STARTED ON 1/15/2021 4PM WITH NUMBNESS, TINGLING RIGHT UPPER EXTREMITY, AXILLLARY EDEMA AND INDURATION WITH SEVERE PAIN AND ELEVATED TEMPERATURE IN AREA, DIFFICULTY WITH ADDUCTION OF ARM, PAIN RIGHT SHOULDER WITH SWELLEING AND RIGHT TORSO PAIN,

Sore throat; Headache/has had an off and on headache since this morning; Nausea; Sore arm/had a sore right arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140, expiry date: Mar2021), via an unspecified route of administration on the right arm on 04Jan2021 (between 16:00- 16:15) at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease about 7-8 years ago. She said she doesn't take medication all the time for the condition. Concomitant medication included azithromycin (Z-PAK), bifidobacterium infantis (ALIGN). Patient had nausea since 06Jan2021. Her sore arm started at around 3:00 AM on 05Jan2021 and lasted only one day. The caller asked if the nausea could be caused by the COVID-19 Vaccine, and if so, should she get the second dose of the COVID-19 vaccine. Reported the nausea is more of an annoyance, and she doesn't feel like she is going to throw up. Her nausea has been persisting since it started on 06Jan2021, but had worsened from 07Jan2021, to 08Jan2021. She said she woke up the morning of 08Jan2021 with a sore throat, and has had an off and on headache since the morning. Outcome of the event sore arm was recovered on 05Jan2021, for the remaining events was not recovered No prior vaccinations within 4 weeks. The reporter considered the event non-serious.

Sore throat; congestion; headache; she will vomit; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program: Pfizer First Connect. A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730, exp date: 31Mar2021), via an unspecified route of administration on 19Dec2020 for COVID-19 immunization. Medical history included being COVID positive on 16Nov2020. The patient had no other relevant history. There were no concomitant medications (no other products). She was working at a doctor's office. The patient mentioned she was due to receive the 2nd dose of the vaccine on 09Jan2021 at 9 am but currently has a sore throat, congestion and a headache (onset date: 05Jan2021). Her symptoms worsened. It started as just a headache. With the congestion now when she blows her nose, sometimes she will vomit (onset date: Jan2021). She was asking if it was okay for her to take the vaccine tomorrow and for any recommendations. She was tested for COVID the day of reporting (08Jan2021) but had no results with her; she hasn't received the COVID test result back (unknown). No investigation assessment performed. The outcome of she will vomit was unknown while the other events had not recovered.

after first dose developed fever 101, shaking chills, anorexia, malaise, and myalgias. Lasted 2.5 days. Eye pain and pressure

1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small rashes with no itch come and go on eyelid, chin, shoulder.

1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone. I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.

Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mild fever; Nausea; Headache; Pain in the muscles and joints; Pain in the muscles and joints; This is a spontaneous report from a contactable consumer reporting for her sister. A 40-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for COVID 19 immunization via an unspecified route of administration from 21Dec2020 to 21Dec2020 at SINGLE DOSE for an unspecified indication . The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 21Dec2020. On 08Jan2021 about 12 hours after the administration of the vaccine, the patient experienced mild fever, nausea, headache, pain in the muscles and joints. The outcome of all the reported events was recovering. The patient received the second dose before the day 21. Information on the lot/batch number has been requested.

Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.

Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, clavicle and neck.

Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.

Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.

Received vaccine at 1100. Patient woke up at 0151 with headache, chills and body aches. Symptoms the same this afternoon at 1200.

"Strep Thoat" Symptoms, itchy throat 25 mg PO Benadryl given BP 148/93 , HR 106, O2 sat 100% room air, RR 20

Arm mildly sore; headache and vomiting after 12 midnight. Headache was positional . Lasted about 36 hours. Ibuprofen

Broke out in a rash on neck and torso. Body aches and headache as well. Treated with Benadryl and Prednisone

Fever; chills; body aches; Date of start of drug: 11Jan2021/ 12Dec2020; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231, expiration date unknown), intramuscular on the left arm 11Jan2021 at 08:00 at a single dose and the first dose (lot number: Eh9899) via intramuscular on the left arm on 12Dec2020 at 08:00 at a single dose for COVID-19 immunization. Medical history included Known allergies to Latex and 1000 island dressing. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 12Dec2020 for COVID-19 immunization and with which the patient experienced fever, chills and body aches. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient has no COVID prior vaccination and no COVID testing post vaccination. The patient experienced fever, chills, and body aches on 11Jan2021 at 20:00, 12 hours post vaccine. The events were resolving.

I woke up at 2:45am with chills, a bad headache, sore arm at test site and nausea. I took extra strength Tylenol and went back to sleep. The following day, I continued to have the headache and fatigue. I took Tylenol and/or Advil all day to keep the headache at bay and also needed a nap. Today, I feel much better.

My left arm was sore with any movement for almost 48 hours. The afternoon after my vaccine I didn't feel great then I developed tachycardia, dry heaves and broke into a cold sweat. The event lasted between 1.5-2 hours.

Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional. A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room. The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.

Throbbing pain; tingling fingers in left arm; pain going up the neck of left side; fever; chills; joint pain (both shoulders, low back, hips, and knee); loss of appetite; fatigue; weakness; headache; muscle pain; This is a spontaneous report from a contactable Other HCP (patient). This 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 08Jan2021 on Arm left at single dose (Lot # 3249) for covid-19 immunisation. Medical history included Osteoporosis, vitamin D deficient. No known allergies. No other vaccine in four weeks. Concomitant medications included other medications in two weeks. She experienced throbbing pain and tingling fingers in left arm, pain going up the neck of left side. Also experience typical side effects: fever, chills, joint pain (both shoulders, low back, hips, and knee), loss of appetite, fatigue, weakness, headache, and muscle pain on 09Jan2021. No Covid prior vaccination. No covid tested post vaccination. No treatments received. Outcome of the events was recovering.

temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

1/22 @ 15:00-low grade fever, chills, body aches, headache 1/23 @ 17:30-noticed swelling in left armpit and Red circle around injection site

101 fever and sever body aches 12 hours after second dose. Extreme fatigue for another 24 hours. 36 hours after vaccine felt perfectly normal again.

Dull headache; still have intermittent headaches; do not need to take anything for it- just reporting for data

Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- muscle soreness at site, migraine that evening, and severe neck pain. Muscle pain in neck and shoulders for a few days causing ha?s in the evenings.

No symptoms or reactions immediately. Injection site was very sore the following day. Followed by body aches, chills, headache, muscle and joint pain. Tired.

Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.

Heart palpitations Chills Freezing hands Chills Stomach pain Body aches Headaches Loss of focus Weak Lightheadedness Dizzy Loss of balance Tingling in lips Swollen throat

Headache before and during, progressed to migraine the next morning 1/22, better 1/23 and feels fine today 1/24

Pfizer vaccine given @ 0956. After vaccine administration, client drove her car to the recovery area and met with the nurse, to show her direction of where to wait for recovery. client informed her, "I think I'm having an allergic reaction." Nurse asked her to describe what symptoms she is having. Client stated that she had an itchy throat, she felt that she couldn't breathe, and her heart was racing. Nurse activated RRT. At 10:00, Nurse responded to scene with the Kit containing the AED, oxygen, and emergency medication. Vitals taken: P: 102, RR: 18, Manual BP: 120/80, Oxygen: 100% RA, no pain. Upon assessment, stethoscope used, clear lungs sounds, normal heart sounds. Client AAO x4, speaking in full sentences, no SOB noted. Skin color normal, capillary refill <3 seconds. Lip color normal. Nurse noted that client's lymph nodes were swollen. Throughout event, client spoke with no SOB and in clear sentences. EMS arrived to scene at 10:09 am. Vitals: HR: 99, 100% RA, 146/98. At this point, client is reporting feeling much better, head-to-toe assessment appears normal. She refused transport via ambulance to the hospital. EMS left scene at 10:20 am. Client was instructed to wait for 30 more minutes for monitoring. Client left scene at 10:30 am with client feeling better. Lymph nodes are no longer swollen, client continues to speak in full sentences with no SOB noted. Skin and lip color normal. Client AA0x4. Client instructed that if she is needing medical attention, feeling SOB, etc., to call 911 or go to the nearest hospital.

Headache and nausea 20 minutes after vaccine given - baseline history of nausea. Resolved after lying supine and a glass of water.

I had a headache the evening after receiving my injection. It?s very rare that I get headaches so I feel it?s associated with the vaccine. The next morning I felt a bit strange, almost like a dizzy sensation in my head that dissipated by the evening. I was still able to move about and do everything I needed to do without difficulty.

I woke up this morning extremely dizzy. I continue to be somewhat dizzy 9 hours later. I also have a headache.

Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emegency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, light headedness, headache, and myalgias. In the emergency department vitals stable and within normal ranges including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted or reported. Patient adminsitered fluids with symptom improvement. Discharged to home stable.

Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.

Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.

beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.

1. ALL started around 4:00pm on 1/24/21-Severe muscle aches, fever (100.8), severe headache, chills, sore throat, nausea 2. Noticed rash on 1/15/21-Rash on right side on stomach, side, and around back

12/23 - FLU LIKE SYMPTOMS (TEMP OF 99.7, CHILLS, BODY ACHES AND SWEATING) WHICH BEGAN AND LASTED APPROX 24-40 HRS AFTER BEING VACCINATED.

Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.

Fever, chills, myalgias, fatigue, generalized weakness , starting 12 hours after the vaccination and lasting approximately 24 hours, except fatigue lasting 2-3 days

I received the 2nd dose of the vaccine on Monday 1/4/2021 at 1600. Over the afternoon and evening I developed arm pain at the injection site. Since there were no other side effects in the morning, I returned to work for my regularly scheduled shift on 01/05/2021 at 0545. At approximately 0615 I began to get body aches and restlessness. At approximately 0725 in addition to the body aches and restlessness, I began to get severe nausea, weakness, light-headedness, headache, profuse sweating, and severe chest pain and shortness of breath. Because of the severity of my symptoms my manager immediately told me to go to the ED and a fellow co-worked brought me down via wheelchair. In the emergency department I was assessed and worked up and after several tests and xrays I was given a diagnosis of adverse reaction to drug/vaccine. I was discharged to home at approximately 1130 on 01/05/2021. Upon arriving home I continued to have body aches, and then developed chills, shaking and fever of 101.00. All of this combined became unbearable and I had to take 500mg of Tylenol at 2230 on 01/05/2021. On 01/06/2021 I still felt horrible with body aches, fever, nausea and fatigue. My weakness, fatigue are still present today 01/07/2021 at 0945.

Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.

Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from a contactable physician (patient) reported that a 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL), ibuprofen and biotin, cyanocobalamin, folic acid (MVI 3). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020 07:15 on the right arm for COVID-19 immunization. On 11Jan2021 21:30 (reported as 'after 12 hours'), the patient experienced severe body aches, chills, headache and temp 100, then after 48 hours (Jan2021) those symptoms resolved, but had GI upset and diarrhea. The patient underwent lab tests and procedures which included body temperature: 100 (no unit reported) on 11Jan2021. The outcome the events severe body aches, chills, headache and temp 100 was recovered on Jan2021 (reported as after 48 hours those symptoms resolved) while GI upset and diarrhea was recovering. The patient did not received any treatment for the reported events.

fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL1287, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 04:15 PM at a single dose on the left arm for COVID-19 immunization. The patient was not pregnant. She received the vaccine at a workplace clinic. She had not received any other vaccines in four weeks. Medical history included arthritis. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL), multivitamin, and airborne immune supplement; these are the other medications she took in two weeks. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via an unspecified route of administration, on 23Dec2020 04:45 PM at a single dose on the left arm for COVID-19 immunization. On 13Jan2021 03:00 AM, within 12 hours of 2nd vaccine dose, the patient experienced fever 101, moderate headache, tachycardia at rest. The patient was not diagnosed with COVID prior to vaccination and had not tested for COVID post vaccination. The patient received no treatment for the reported adverse events. Outcome of the events was recovering.

headache; chills; tiredness; nausea; feeling unwell; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 40-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in left arm, on 11Jan2021 00:00 (reported as 12:00AM), at single dose, for COVID-19 immunization, in workplace clinic. There was no medical history. Concomitant medication was not reported. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient is not pregnant. The patient experienced headache, chills, tiredness, nausea and was feeling unwell all on 11Jan2021 14:30. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The outcome of the events was recovering.

nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.

36 hours after the injection I developed large red, warm and painful area at the injection site. 24 hours after that I was experiencing fever and chills again. I also started to vomit

After my 1st vaccine I felt dizzy and experienced headaches. I tested positive for Covid 19 on 12-30-2020.

After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.

After second dose about 16 hours after experienced chills bodyaches sore joints muscles and low grade fever and fatigue

Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).

Case received dose at 11:25 am and at 12:25 pm felt a rush of heat throughout her body, back of throat "fuzzy", heart rate 140/min for 20 minutes. Her breathing was as if she was "trying to catch my breath" which lasted 5 minutes. At 1pm she experienced fatigue, chills, had fog, and weakness which lasted or approximately 18 hours. She felt much better 48 hours later.

Dizziness, fatigue, nausea and vomiting, fever of 102. Felt very weak for 24. Dizziness remained after other symptoms resolved.

I experienced fatigued and headaches after my 2nd dose injection. I tested positive for Covid 12-30-2020.

I received the second dose of the vaccine on 1/4/21 and experienced fatigue, muscle aches, headache, and a fever of 99.6 beginning 36 hours after the vaccine was administered extending to about 60 hours after administration. I missed work on 1/6/21 due to symptoms.

Later on the day of vaccination I started feeling fatigue & pain on the site of the injection. I had continues fatigue & muscle pain this lasted about 5-6 days. On 12/28/2020 I started noticing that I developed shingles on my right side of forehead also experiencing pain till current. I saw my doctor on 12/28/2020 & prescribed medication.

Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020 Improvement with ibuprofen and acetaminophen. Resolved by 1/25/2021

On 27th - headaches; body aches and lethargy; following day, 28th and 29th, I had stuffy nose and sore throat.Tylenol and Vitamin C - 1 gram a day; I was tested for COVID on the 30th and was positive on the 1st. Quarantine until Jan 6 of January; second dose on 7th. My symptoms resolved before second dose. I had chills and body aches after second dose for 72 hours and then those resolved.

RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.

Starting 6-7 hours after the vaccine I began to have the most severe ear pain that would not go away with Tylenol/ibuprofen. I was unable to get up/sit up on my own. My lumbar spine seized up and spasmed feeling like I had an acute injury. I had chills but no fever.

body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.

heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.

woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.

Both arms hurt; Fatigue; Headache that moves; Ear aches; Noises are louder; Mind goes blank while recalling information in a conversation; Feverish feeling but no fever; Heaviness of the body like moving in honey; Achiness; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248, expiration date not reported) via an unspecified route of administration on the right arm on 12Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included PCOS, Raynauds, PTSD; and known allergies: Sulpha, sulfites, pseudafed, penicillin, cephalosporins, bromfed, IV contrast, pineapple. Concomitant medication in two weeks included levocetirizine dihydrochloride (XYZAL), omeprazole, escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL) and levothyroxine sodium (LEVOTHYROXIN). On 12Jan2021 08:45 PM, the patient experienced both arms hurt, fatigue, achiness, headache that moves, ear aches, noises are louder, mind goes blank while recalling information in a conversation, feverish feeling but no fever, heaviness of the body like moving in honey. Therapeutic measures were taken as a result of the events which included Ibuprofen (ADVIL) and acetaminophen (TYLENOL). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.

Fever since evening of the injection, continuous headache, muscle aches, unable to work today, palpitations, general malaise.

Headache; fatigue; chills; nausea; vomiting; fever up to 101.4; sweating; This is a spontaneous report from a contactable other hcp. A 40-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported) via an unspecified route of administration on the right arm on 12Jan2021 03:45 at single dose for COVID-19 immunization. Medical history included migraine and acid reflux from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medication included pantoprazole for acid reflux. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685, expiry date not reported) on 22Dec2020 on the right arm for COVID-19 immunization. The patient experienced headache, fatigue, chills, nausea, vomiting, fever up to 101.4 and sweating on 13Jan2021 12:00. The patient underwent lab tests and procedures which included body temperature: 101.4 on 13Jan2021. The patient recovered from the events on an unspecified date. No treatment was given in response to the events. The patient had no COVID prior to vaccination and has not COVID tested post vaccination.

Patient is a healthcare worker who received the first dose of the COVID-19 vaccine. Later that day, patient had excessive fatigue and some site injection pain. The next morning patient has loss of consciousness witnessed by husband. At the same time patient was drooling, not speaking clearly, and then eyes rolled back in her head, and passed out for a few minutes.

Went to hospital in middle of night when resting heart rate was 136/ woke up in middle of night with racing heart/was 133; chills; fever; body aches; swollen axillary lymph nodes; rash on shoulder, armpit and back close to the vaccine site; bad headache; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) from 13Jan2021 10:45 to 13Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included asthma and hypothyroidism. Concomitant medication included beclometasone dipropionate (QVAR) and levothyroxine. The patient also has allergies to Codeine and Azithromycin. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020. Information on the lot/batch number has been requested. It was reported that the patient went to the hospital (Emergency Room/Urgent Care) in the middle of the night when her resting heart rate was 136 on 13Jan2021. She had fever, chills, body aches. She woke up in the middle of the night with racing heart. Was 133 in the hospital, they gave her 2 liters of fluids which eventually brought it down to 105. They ran a lot of test and ruled out anything else. On Jan2021, they also found swollen axillary lymph nodes. It's now 48 hours later, still have a fever, HR finally is below 100, she now has a rash on her shoulder, armpit and back close to the vaccine site and she have a bad headache. The outcome of the event fever was not recovered while recovered with sequel on unspecified dates for the other events.

employee became light headed, dizzy and nauseous. 10-15 min after vaccine. 0956 vitals were taken and employee was asked to lay down on cot (vitals 143/83 p 90) 1003 employee began to have seizure like activity a rapid response was called at 1008. Employee refused to go to ED , husband notified. 1020 Benadryl was given per MD continued monitoring until 1135 employee was recommended to go to ED by MD , she refused stated she was ok just tired. Assisted to vehicle with husband at 1140

weakness; confusion; dizziness; headache; hypotension; diarrhea; fatigue/lethargy; fatigue/lethargy; nausea; unilateral pain; photophobia x 3 days; Vomiting; This is a spontaneous report from a non-contactable Other HCP (patient). This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 14Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 40-years-old. No other vaccine was received in four weeks. Medical history included migraines, IgM, and MGUS. Historical vaccine included first dose of BNT162B2 in left arm for COVID-19 immunisation. Concomitant medications included fremanezumab (AJOVY), escitalopram oxalate (LEXAPRO), and NURTEC (as reported). On 14Jan2021, the patient experienced vomiting, nausea, hypotension, weakness, unilateral pain and weakness, dizziness, confusion, headache, fatigue/lethargy, diarrhea, photophobia x 3 days. Events were recovering. No treatment was received for the event. No follow up attempts are possible; information about lot/batch number cannot be obtained.

Arm and face swelling, fever, bloodshot eyes, rapid heart rate, body pain, nausea, and headache. Took Tylenol, fluids, Benadryl, and rest.

Day 2 after injection just injection site pain and tired. Severe hips/knees/ankles/wrists/back pain on day 5 and 6 after injection and calves pain and tightness.

I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.

I woke up at about 1am, feeling achy and with the chills. I had a fever of 102. I took Tylenol and went back to bed. I woke up about 8 feeling exhausted and achy. I took more Tylenol and started to feel better for a few hours. About 12pm I started to feel worse again and took a nap until about 3pm. When I got up at 3pm I had the chills and could barely get out of bed. I had a fever that alternated between 104 - 105 until 6pm. The fever broke around 6pm and I was still a bit achy and exhausted, but started progressively feeling better. I felt totally fine the next morning.

My body turned cold then followed by hot flashes coughing with blood. Low fever muscle pain but I had bronchitis two weeks prior next day cough wheezing completely gone and my lungs feel great I can breathe again with no mucus I have swollen lymph nodes but not to bad little headache but overall feeling ok just tired and some dizziness at times.

Vaccine taken at 6:30 am. Soreness in left arm started around 8-8:30. Felt tired all day but after a nap around 11:30ish felt nauseous, ate to try and calm it but it got worse throughout the day especially at night around 9pm finally relaxed enough to fall asleep, woke up at 7am feeling more nauseous than yesterday with a bad headache located in the front of my head not throbbed but constant. Laying down just felt really sick so I called my doctor around 9:15am.

approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also had intermittent itching and chills. Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home

Patient reported coughing and shortness of breath 1 hour after Covid vaccine.Pulse Ox 99%, lungs clear, P 88, cough noted. Patient given 25mg oral Benadryl. Coughing subsided

Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had increase in arm pain, not able to move it, body aches, chills, nausea, and fatigue. symptoms remain today.

Severe headache; body aches; Chills; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK5730), intramuscular in the left arm on 28Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant. On 29Dec2020, the patient experienced body aches and chills. After 1 week on 05Jan2021, the patient experienced severe headache. The patient has not tested positive for covid post vaccination. The patient did not receive treatment for the events. The events recovered on unspecified date in Jan2021.

She pretreated with Claritin and tums. About 20 minutes after the injection she began having tingling and numbness in her mouth that persisted all day. The following day the tingling had improved but there was residual numbness. She also noted fatigue and body aches.

chest discomfort/something heavy on her chest; cannot even get out of bed; cannot cook right/ cannot do her daily duties/ could not even put her seat belt or roll up the window in her car; extreme headache; received first dose of the vaccine on 24Dec2020/the second dose on 11Jan2021; Chills; feeling horrible/feels foggy; feeling tired/ exhausted; body aches; arm was really sore; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), intramuscularly on 11Jan2021 07:45 at single dose in left arm to prevent covid, since she worked in a hospital with covid patients. Medical history provided as none. There were no concomitant medications. She gets the flu vaccine annually. The patient previously received first dose of BNT162B2 vaccine intramuscularly on 24Dec2020 23:45 in left arm for COVID-19 immunization with no adverse events. There were no other prior Vaccinations within 4 weeks. The patient experienced chills on 11Jan2021, feeling horrible on 11Jan2021, extreme headache on 12Jan2021, chest discomfort/something heavy on her chest on 13Jan2021, feeling tired/ exhausted on 11Jan2021, chest discomfort, feeling tired/ exhausted was reported as worsened; body aches on 11Jan2021, feels foggy on 13Jan2021, arm was really sore on an unspecified date in Jan2021, cannot even get out of bed on 12Jan2021. Specifically, it was reported that the patient worked 12 hours overnight, she slept and when she woke up she felt chills and felt horrible. States it carried on 12Jan2021. Today on 13Jan2021 she has an extreme headache, she clarifies the headache started on 12Jan2021 (yesterday). She feels like something heavy on her chest, chest discomfort. She has body aches and feels tired. She cannot cook right, she is so exhausted and cannot do her daily duties. She is assuming it is the immune reaction. Her son told her she looks really sick. States she rarely gets sick and when she gets sick she does get chills. Her chest feels like something is heavy on her. States if she did not have a strong heart, she cannot imagine what someone that does not have a strong heart would feel like. Since she works in a hospital she deals with covid all year around and she has been strong and healthy this year. Reports her headache is strong and today on 13Jan2021 she feels foggy. States yesterday on 12Jan2021, she was horrible and today (13Jan2021) is better in regards to chills. Her arm was really sore and now her arm is better, she could not even put her seat belt on 12Jan2021 (yesterday) or roll up the window in her car. She is nervous about the chest discomfort and headache. Asking where it could be coming from. She thinks it could be a possible immune response. If the chest discomfort continues she will go get seen. Advised to contact hcp. States she feels like crap. States she never gets headaches. Yesterday on 12Jan2021, her body aches were horrible and she cannot even get out of bed. The outcome of events chills, body aches was recovering, outcome of events extreme headache, chest discomfort/something heavy on her chest, feeling tired/ exhausted was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.

severe chills, body aches, joint pain, small patch of hives by left shoulder. Took Tylenol and Advil

Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache. Lasted approximately 12 hours

Elevated temperature (almost 100); Feel weak and shaky; Feel weak and shaky; Coughing; Nasal congestion; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (Vaccine location: left arm) on 20Jan2021 11:45 for COVID-19 immunization. Facility where the recent COVID-19 vaccine was administered: Other-Drive thru vaccine POD. Medical history included Hashimoto's thyroiditis, allergies to penicillin, and sinus infection. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Other medication the patient received within 2 weeks of vaccination included doxycycline 'hydroxylate' for a sinus infection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 12:00, the patient had an elevated temperature (almost 100), felt weak and shaky, coughing and nasal congestion, and a headache. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events. No follow-up attempts are possible; information about batch number cannot be obtained.

I felt extremely hot/cold sensation in a claustrophobic; I felt extremely hot/cold sensation in a claustrophobic; nauseous; Dizzy; headache; fatigue/I'm just exhausted 72 hours later; fever kept rising; I started violently projectile vomiting for a few hours; I got the chills; I was sore; felt "hungover"; the arm soreness; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her right arm, intramuscular on 16Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included anxiety, acid reflux and cholecystectomy. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), clonazepam (CLONAPAM) and an unspecified antacid. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 as first dose. It was reported that 12 hours later after vaccination, the patient felt really hot and nauseous, dizzy, headache and fatigue. But then 24 hours later her fever kept rising. She felt extremely hot/cold sensation in a claustrophobic. At peak of her fever, 100F, she started violently projectile vomiting for a few hours. Then she got the chills. Felt nauseous still. But no more vomiting, fever went down on its own. The next day 48 hours later, she was sore and felt "hungover". This time the arm soreness dissipated twice as fast. Now she just exhausted 72 hours later; all events occurred on 17Jan2021 at 02:00. No treatment was received for the events. The outcome of the events was recovered with sequel.

The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.

tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.

Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle aches; vomiting still after 8 days.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history included bipolar disorder and ovarian cyst. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included trazodone, desvenlafaxine succinate (PRISTIQ), and oxcarbazepine (TRILEPTAL). The patient previously took morphine sulfate and experienced allergies. On 12Jan2021 19:00, the patient experienced dizziness, extreme fatigue (unable to drive and doze off during conversations), headache, muscle aches and vomiting still after 8 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.

Report left arm soreness and HA 6 hours after vaccination: Treatment: Tylenol with no improvement. Outcome: unable to go to work, but does not interfere with ADLs.

nausea; severe headache; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3249, expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and sertraline. On 17Jan2021 05:00 AM, the patient experienced nausea and severe headache. The facility where the vaccine was administered was the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Therapeutic measures were taken as a result of the events which included naproxen and acetaminophen (TYLENOL). Outcome of the events was not recovered.

Shortly after the vaccination I was still having the abdominal distention so I called to see if I could defer the 2nd vaccine because I wasnt feeling well and still experiencing AE from the 1st dose. I was advised I still had to get the vaccine so I did and by 2:30pm I begin to have severe facial swelling causing asymmetrical shaping of my face, my head was hurting extremely bad, fatigued and felt really bad. I had to lay down because my head was hurting, felt like I had pressure on the top of my head, neck and back. The pain was so bad I was transported to the ER and was isolated d/t previous COVID infection and all while there the my body felt as if it was steady swelling. I was hurting so bad I couldnt stand to be touched. I was given another round of steroids. I was advised I had COVID pnemonia and was given IM decadron, IM regalin and a subQ injection of immatrex for the headaches and administered ibuprophen and tynenol for the headache as well. I was discharged with a prescription of regalin and decadron. The ER dr. states I shouldnt have taken the 2nd vaccine because I was still suffering from COVID-19. The abdominal distention had dissolved but the congestion just will not clear up even after 3 rounds of steroids. Asoumedrol was prescribed by my ENT but it didnt help either so I have a CT Scan scheduled for next week with my ENT and has not been able to return to work since the 1st dose 12/22. I have be retested for COVID-19 on both 1/15 and 1/25 and both results are still positive for COVID.

With the 1st dose I had myalgia, arthralgia and pain at the injection site which began the next morning when I woke up at around 10:00 am and lasted 48 hours. For the 2nd dose, the reaction was more profound. I had pain at the injection site within 6 hours of the injection and by the next day around 11:00 am I woke up with myalgia, arthralgia, fever of 101.2 F, fatigue, headache, and sore throat. Symptoms lasted for 4 days and I missed 2 days of work.

felt like she was running a fever; didn't feel well; when she stood up to use the bathroom...she was standing and felt dizzy, like she was going to black out; she was standing and felt dizzy, like she was going to black out; heart was racing; pale; sweating/drenched her clothes in sweat; felt so weak she could not get back to my bed; breathing was rapid; stomach pain; diarrhea; patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0142), via an unspecified route of administration in the left arm, on 14Jan2021 15:15 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient received the first dose of bnt162b2 on 21Dec2020. She received the second dose on 14Jan2020. Then, it was about 12 hours later (15Jan2021 at 04:00), when she stood up to use the bathroom. She felt like she was running a fever and didn't feel well: she was standing and felt dizzy, like she was going to black out, her heart was racing, and she had to lie down. She was pale and sweating; and felt so weak she could not get back to bed. Patient's husband had to help her. These feelings lasted for about 25 minutes. Patient drenched her clothes in sweat and her breathing was rapid. Then she got stomach pain and diarrhea. The outcome of events was recovered on Jan2021. The patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Onset of headaches 24hrs post injection. Continued headaches every day since. Going on week 3 of headaches.

CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN, GREY COMPLEXION, MALAISE, GENERALIZED JOINT PAIN. DIFFICULTY RAISING UPPER EXTREMITIES DUE TO PAIN AN MUSCLE WEAKNESS,

Temperature of 102; body aches; chills; headache; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. the patient was not pregnant. Concomitant medication included celecoxib (CELEXA) and vitamin D. The patient previously took stadol and experienced allergies. Patient previously received the first dose of bnt162b2 (lot number: EJI1686) on 29Dec2020 via intramuscular in the right arm for covid-19 immunization and experienced Right sided supraclavicular lymph node enlargement and pain. On 20Jan2021 01:00, 24 hours after the vaccine administration, the patient had a temperature of 102 body aches, chills and headache. The outcome of events was reported as "recovering". The patient did not receive any treatment for the events. the events were considered as non-serious. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

on the morning on 2/6/2021 at 6am, swollen lymph nodes under left arm, migraine, vomiting and diarrhea, fever 99.8. Did not feel well through 2/8/2021.

Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's mother). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Patient age at vaccination was 40 years. The patient's medical history and patient's concomitant medications were not reported. The reporter stated the patient had COVID-19 vaccine 3 weeks ago and she will have the 2nd dose of vaccine 'tomorrow'. The reporter was kind of nervous about her getting the 2nd dose as the patient is experiencing a sweat breakouts and almost going to pass out, she sees the room as color yellow and red. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and breast (all L) Neck pain; armpit and breast (all L) Neck pain; This is a spontaneous report from a non-contactable Other HCP (patient). A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 15:00 for an unspecified indication Covid-19 immunisation. Medical history included irritable bowel syndrome (IBS), asthma, allergies to sulfa. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 20Jan2021 the patient experienced headache extreme, fatigue, pain at injection site, armpit and breast (all l) neck pain. No treatment received. COVID was not tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

I had Chills, low grade fever, site sorness, arm stiffness, worsened joint and muscle pain and fatigue for 3 days

Raised rash on face; Raised rash on face and injection site; flushed feeling face; chills; Body aches; brain fog/ overall not up to feeling like myself; This is a spontaneous report from a contactable nurse reported for herself. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 22Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing and cerebrovascular accident from an unknown date and unknown if ongoing. The patient previously took morphine and experienced drug hypersensitivity. On 23Jan2021 10:30, the patient experienced raised rash on face and injection site, flushed feeling face, chills, overall not up to feeling like myself, body aches and brain fog. No treatment was received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

blurry vision, kaleidoscope vision accompanied by a headache - entire body soreness, soreness at injection site

my feet feel so cold like ice; tingling to my hands and feet/Hand & feet tingling; leg weakness; felt like my heart pounding and racing/ fast heart rate; feeling too sick; started to feel flu like; muscle pain; fatigue; The initial report was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 24Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via intramuscular route of administration in the left arm on 15Jan2021 09:15 AM at a single dose to prevent COVID-19. Medical history included known allergies: latex. Concomitant medications in two weeks included ergocalciferol (VIT D) and cyanocobalamin (VIT B12). The patient did not have any other vaccine in four weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular route of administration in the left arm on 26Dec2020 10:30 AM. She also previously took NYQUIL and experienced known allergies. The patient was not pregnant and was not diagnosed with COVID prior to vaccination. The patient stated "I started to feel flu like around 7pm on January 15th. I had extreme muscle pain and fatigue. I woke up at 2am with what felt like my heart pounding and racing. The fast heart rate lasted about an hour. For the next +5 days, I had extreme fatigue, taking 3 hour naps at a time and still suffering from muscle pain. I attempted to go to work a couple of those days but went home half way through my shift because I was feeling too sick. Friday morning, 22Jan, I woke up feeling like I had leg weakness but I was still able to do activity normally. Saturday morning, 23Jan, I woke up with tingling to my hands and feet. I even had trouble typing at work. I made it through my shift this day with waves of muscle pain, fatigue and constant tingling to my hands and feet. Today Sunday, 24Jan I still have hand & feet tingling and my feet feel so cold like ice. I still feel 'off' overall. I plan do see my PCP this week to discuss these new symptoms in my hands and feet." The patient did not receive treatment for the events. She was not tested for COVID post vaccination. The outcome of 'heart pounding and racing/ fast heart rate' was recovered, and of remaining events was not recovered.

Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.

About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.

red rash came up on her chest; upper chest muscles just below her collar bone. the pressure of the water hitting her was painful; Diarrhea; pain and stiffness in her chest that extended across her shoulders; can't seem to regulate her body temperature; laboring to breathe; joint pain; pulse and it had dropped down to 40; She has a history of tachycardia, but her pulse kept reading normal; muscle pain; inflammation; she woke up and she was itchy around her left forearm. She was really itching; couldn't really taste, things didn't really taste right to her; immediate soreness in arm; she has pain that extends up into her neck; Nausea; hasn't had much of an appetite; sweating; left hand swelling; hives on forearm; gastrointestinal issues; Fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), intramuscular at left arm on 21Jan2021 15:38 at a single dose for COVID-19 immunization. Medical history included Tachycardia (started about 4 years ago), Hypertension (started about 4 years ago) and Essential tremor from 2020 (she has been having symptoms for a while; finally, during the summer of 2020, she was diagnosed through a neurologist) and anxiety, all ongoing; pain, back problems and sleep disorder.Concomitant medications included ongoing Tizanidine as muscle relaxant for back problems, ongoing Metoprolol tartrate for hypertension and tachycardia, Primidone for Essential tremor and ongoing Clonazepam for essential tremors, to help her sleep, and also for anxiety. No prior vaccinations (within 4 weeks). The patient got the first COVID vaccine dose. Afterwards, she went to school and it "was downhill from there". 5 days of persistent symptoms including sweating, muscle pain, joint pain and left hand swelling. It was further reported that she had to wait 15 minutes and then she drove home which is about a 35-minute drive. So about 45 mins after receiving the vaccine, she noticed her tongue, it was more on the right side of her tongue, she can't explain the sensation. She couldn't really taste. Things didn't taste right to her. This lasted 24 hours. She woke up the next day, 22Jan2021, feeling not quite right. She took some Tylenol that morning and went on into school. She took some ibuprofen in the middle of day, it wasn't a big deal. She has a history of tachycardia, but her pulse kept reading normal. She had a drink she was drinking from lunch and she ended up having the remainder of it the last few hours of that day. At about the end of her workday, around 15:30 she was finishing the Cdrink off and she said to herself "oh that taste like a regular drink again". This tongue sensation/lack of taste resolved. At that point, she got really excited because she thought this was all that she would experience with the vaccine. She was grateful she had the chance to have the vaccine. She mentions her arm was very sore right off the bat. She experienced immediate soreness in her arm right after receiving the COVID-19. She thought when they were injecting her, it hit her bone. In fact, she joked about this with the person administering the vaccine. The person at the facility told her to rub it, it actually helps with that. This kind of soreness didn't seem like a major problem. She was still experiencing this soreness. If she is sitting on the couch sideways, with her side of her arm against the couch, she has pain that extends up into her neck. It was pretty painful. Friday, 22Jan2021 (24 hours later after receiving the vaccine), by the time she got home from work, she was really sore. She had some real muscle pain around her hips and upper thighs, both of them. The soreness extended across. It was like she had inflammation that started flaring up. She felt pretty sore that evening. It wasn't like a normal muscle soreness. She went to bed because she was pretty tired. The next morning (Saturday, 23 Jan 2021), she couldn't get off the couch. She had such bad muscle and joint pain. She slept off and on, the pain was pretty bad. Her whole body had so much stiffness and inflammation. Every muscle and every joint just hurt. She confirmed that she hasn't been able to regulate her body temperature. This has been going on since Saturday evening (23Jan2021). She stated that this wasn't normal for her. She does take medications to lower heart rate but she hadn't taken it. She was talking to her best friend about how she had been sore and slept all evening. She checked her pulse and it had dropped down to 40. Her O2 level was at 92. She didn't think it was that big of a deal. Her best friend was kind of freaking out about it. She had such pain and stiffness in her chest that extended across her shoulders, it made it difficult to breathe. She was laboring to breathe. She checked her pulse thinking maybe she was feeling anxious about it and her HR was up, but it wasn't. She states happened so bad yesterday, yesterday was worse than before. She got up on Sunday morning, 24Jan2021, and took a hot shower. When the water from the shower head hit her chest, clarified as her upper chest muscles just below her collar bone, the pressure of the water hitting her was painful. However, she was able to get up, she was moving around. Still the whole time. she had this fever-ish feeling. Her kids were telling her that they were sweating because she had the house at 76 degrees. Monday morning, 25Jan2021, she woke up and she was itchy around her left forearm. She was really itching on Friday night, but she didn't think anything about it. When she took a hot shower yesterday (25Jan2021), a red rash came up on her chest and it looked like she had hives on her forearm. She didn't know if the hot water flared that up, but she doesn't have any allergies. She also had gastrointestinal issues. She has had some nausea that has lasted the entire time since she received the vaccine. She clarifies the nausea has came and gone. She hasn't had much of an appetite. They thought she had a fever yesterday at school. It was 99. something but she had already taken Tylenol a couple hours before and she was sweating so much. She states she has also had diarrhea the last few days, clarified as the last 2 days (24Jan2021). She has already spoken to someone to report her symptoms but wasn't sure about and had question about getting the second vaccine dose. She reported having gone to Urgent care where she was told she had Post covid vaccine syndrome and that she shouldn't have a problem with the second dose. She explained she went to the urgent care yesterday, 25Jan2021. She called her doctor that morning and was told to continue to treat her symptoms and take ibuprofen and Tylenol but if she got worse, to go to urgent care. So, she went to the urgent care (Product information for the Tylenol and Ibuprofen she has been taking (Ibuprofen: UPC/NDC: not provided when probed. Lot: P142385 Expiry date: Apr2023 and Tylenol: UPC/NDC: not provided when probed. Lot: P121664 Expiry date: Sep2023). The nurse just explained (Name Withheld) was having the same exact symptoms as the patient, except it was (Name Withheld) second dose. Her symptoms were identical to the patient. The patient wasn't initially sure if it was from the vaccine or if it was her anxiety. The patient didn't feel anxious and her heart rate wasn't up. The patient told she didn't think anxiety caused her to feel like she had a fever. The school nurse looked it up and found out more symptoms kind of wax and wane. Her symptoms got much worse. On 25Jan2021, Test: Rapid COVID-19 test Result: Negative. The event immediate soreness in arm was not recovered; event couldn't really taste, things didn't really taste right to her recovered on 22Jan2021 and nausea recovered in Jan2021; and unknown outcome for the other events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101606 same reporter/drug, similar events, different patient

mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.

tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.

After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.

malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks

Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.

Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.

Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.

mild headache 10 hrs after 2nd dose; malaise in the morning, the day after 2nd vaccine administration; took tylenol and felt normal within an hour

Client complained of itchy throat. seen and assessed by EMS. Vitals are as follows: B/P 107/72, HR-109, O2-99. Client denies any other symptoms and verbalized decrease is sensation. Client cleared by EMS to go home. Client advised to seek MD if symptoms worsen.

Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.

Headache lasting greater than 1 week, extreme fatigue and vaginal bleeding. Normally no headaches and very regular cycle

Patient had witnessed seizure like activity for 30 seconds. Patient transported to ER on Gurney with RN All extremities contracted with grunting Airway maintained After activity was alert pale diaphoretic

40 y/o female who developed anaphylaxis to Pfizer vaccine. Pt first developed itchiness of throat , followed by generalized pruritus and the sensation of "throat tightening." Received epi from medical team but initially refused ER visit. Symptoms resolved but returned 15 mins later with numbness of the lips and throat, sensation of throat closing being additonal symptoms. She was agreeable to transport after the second episode.

Client complained of warmth and dizziness after receiving first Pfizer Covid-19 vaccine. Client was sitting in post vaccine waiting area approximately 10 minutes before alerting EMT she was not feeling well. EMT alerted lead PHN to assist. Client alert and oriented, faced appeared slightly flushed, PHN asked client to lower mask to assess for any swelling or hives. Client denied shortness of breath, chest pain, allergies to vaccines in the past. Client stated room feeling warm. First set of vitals at 1020: blood pressure 124/80, pulse 79, respirations 16. Client was moved to chair near exit door for breeze of air and given water. Client walked with steady gait by herself. Shortly after being closer to open doorway client stated warmth feeling was improving. Per client only allergic to gluten products, only medication she takes is for thyroid and she had taken that this morning. Client asked if she could eat her snack she had in her purse, per client no breakfast this morning. PHN just instructed client to take small sips of water and eat slowly. PHN informed client her wait time would be extended to 30 min observation to make sure symptoms had improved prior to her leaving and client agreed. EMT stayed with client and reassessed vitals after 5 minutes. Blood pressure: 128/80, pulse 75, o2 98, skin color normal, alert and oriented, and client stated symptoms resolving. PHN and EMT reassessed client at 10:40, as client was approaching 30 minute observation. Vitals: blood pressure, 128/78, pulse 78, o2 99. Alert and oriented, client stated prior complaints had resolved. PHN had patient stand up by chair to assess for dizziness and client denied at this time. ER precautions given. EMT walked client out of building at 10:45, client walked out with steady gait.

About 12 hours after the vaccine, I experienced a 102 degree temperature, all over body aches with the most discomfort in my lower back, knees, and hips, headache and general fatigue. The next day all the symptoms went away except residual arthritic joint pain. The pain is more extreme during sleep and in the morning. My left knee has been swollen as well. There is a general feeling of whole body arthritis and is lessened by NSAIDs.

After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information about batch/lot number has been requested.

Blood pressure jumped to 172/110. Immediate headache Almost a numb or tingly feeling spread throughout my body My chest, arms and legs felt heavy. It wasn?t hard to breathe exactly, but it just felt like it was hard to actually do it. If that makes sense Then, the scary one. My brain and my mouth were saying two different things. I became really pale (per medic) and I had a hard time figuring out how to say no. My mind just wouldn?t work correctly. And when I tried to speak, it was very confusing and I was told I wasn?t making sense by the medic. Then as quickly as it started, it stopped. Periodically through out the day today, I have gotten more confused than normal about simple things. Earlier I tried to say chicken. I said potato. I was thinking chicken but my stupid mouth said something different. The medic compared my symptoms to a stroke. Which was terrifying

Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old female non-pregnant patient received first dose of bnt162b2 (formulation: Solution for injection, Brand: Pfizer, Lot number: unknown) via unspecified route of administration at 12:15 on 27Jan2021, on left arm at single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included CELEXA (celecoxib), NEXIUM (esomeprazole sodium) and ZYRTEC (cetirizine hydrochloride). It was reported that on an unknown date in Jan2021 at 07:00, the patient experienced headache and pain at injection site. The events were reported as non-serious by the reporter. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

I was about 9 weeks pregnant with no complications at the time of my second vaccination. Estimated due date was 08/24/2021. I began bleeding and cramping and having headaches approximately 10 days after my second dose. I sought medical attention and was told that my baby no longer had a heart beat and that growth (based on ultrasound) had stopped around the 9 week mark. I had medical assistance to physically miscarry the deceased fetus. I have one healthy living son (2 years, 4 months old) who was delivered without complications naturally.

Started feeling lethargic and weak at 6:30pm 2/28/21. Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.

arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.

felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Once injected, I felt a Swooshing in my brain, immediate numbness in my arm and fever in fifteen...nurse had me lay down for ten mins. Still felt weird and numb in arm, she said it was normal and sent me to leave. Tem mins into my car ride home my left cheek starting tingling and going numb. The nerves in my left leg began tingling all over. By the time I got to the hospital, I had similar symptoms of Temporary paralysis on left side yet my limbs were still functioning. When I left the hospital a few hours later, I was like 50 percent numb on my left side, all test results showed everything was good, blood, EKG and cat scan. I felt like I'd been injected with novacaine all over the left side of my body and I was in the stage where it is starting to wear down with tingling and itching on my hand leg and cheek on my left side. My back on left side and neck locked up. The numbing in my face took two weeks to decipate. While exercising never agitation occurred and felt like nerves were firing for two weeks. Severe ear nerve pain occured within first week. Followed up with personal doctor had mri of brain w/ and without contrast and that looked good. I am pretty healthy, maybe a few extra covid lbs. EKG good, CT scan good, blood work good. I am waiting to see neurologist for more testing. There is still random tingling in and out, very faint on left side of my body only. Use of my left hand feels

chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.

2/25/2021- Admitted to hospital following severe high-grade fevers and headaches. Received her second dose of Pfizer COVID vaccine on 2/24/2021. Reported fevers as high as 105 at home. Admitted for IV hydration. Her fever persisted 24 hours after admission and headaches got worse. Patient started on Topamax with better control of headaches. Fever subsided 24 hours prior to discharge. Discharge home on 2/28/2021.

Chills, sweats, fever 102.5+ for about 18 hours, body aches/pains (including bottoms of feet and palms of hands), headaches, nausea.

Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 16Feb2021 10:00 AM (age at vaccination was 40 years old, vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 26Jan2021 11:15 AM (vaccine location: Right arm) at single dose for COVID-19 immunisation. The patient's medical history included environmental allergies. The concomitant medications were reported none.Patient experienced chills, body aches lasting a while, joint pain everywhere and headache, all starting 14 hours and 30 mins after second dose on 17Feb2021.The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.

General lethargy, weakness, overall body aches and chills, fever and chest pain, tightness in back of throat

Histamine reaction: red, hot sweaty cheeks that became a little puffy; slightly itchy lips; red splotchy patches on parts of my legs, chest, feet (mostly toes), and hands (mostly fingers). Started with my cheeks within minutes of the shot, got worse over the next hour. It took about 4-5 hours to dissipate. But even the next day, I have been a little itchy.

I developed a very bad migraine about 4 hours after getting the vaccine that lasted all night and the next day my arm was very tender where I got the shot. The adverse side effect I'm most concerned about developed 2 days later. I noticed it hurt to turn my head and realized I had a lump on the right side of my neck sort of under my chin but a little to the right of that. It's making my throat hurt even though my throat itself is fine and the pain from this knot is radiating up to my right ear. I'm sure it's a swollen lymph node. I've had swollen lymph nodes before with strep throat but never have they hurt as much as this is and I've never had just one lymph node swell until now. I got the shot on a Saturday and this symptom began on Monday. I've been dealing with it for 3 days now, so if it's now gone in 2 more days I'll be going to my doctor for evaluation. I just wanted to report this and I was also wondering if this reaction has anything to do with the brain tumor surgery I had for an acoustic neuroma brain tumor and they put a metal plate in my head that my body had a bad reaction to causing hives, itching, and a lot of extra pain and irritation.

Patient received the COVID-19 Pfizer vaccine at 08:41 am on 2/28/2021. Patient began to experience tongue swelling and her throat tightening. At 9:35 AM, Diphenhydramine 50mg IM Injection was given in the Right deltoid. Diphenhydramine lot number 6124005, EXP 04/22. At 9:48 AM, Patient continued to sound and feel throat raspy and coughing, patient was given an Epi pen into her right thigh. Epi pen lot number 0FM501, EXP 05/22. Patient was also given Solu-Medrol 40mg injection into the right glute at 10:30AM. Solu-Medrol lot number DP2618, EXP 01/22.

Pt reports she is 22 weeks and she states OB give her go ahead to get vaccine. Vaccine given at 0925. 0930 pt reports started sweating. b/p 128/83, hr-106, 02 sat 97% ra, r-18. No other issues noted. Water given. 0945 hr-104, 02 sat 98%ra, r-18. Pt cont to be sweaty per report. 1006 02 sat 97%ra, hr-97 pt reports starting to feel better not as sweaty. 1018 02 sat 96%ra, b/p 132/76, p-90 pt repots all sweatiness gone just clothing wet. Got up walked around no issues noted. Pt instructed to f/u with MD prn. Escorted to car by staff member. No issues noted while walkiing to her car.

Rash from latex: Rx steroid ointment for earlier unrelated rash, Benadryl Wine flush/congestion: nothing Face swelling/redness/shortness of breath: Benadryl

Pt reported feeling unusually hot and diaphoretic about 2 hours after receiving vaccine. Blood pressure was running high with reports of 164/92, 169/102, 144/98 and then 135/89. Taken 10 minutes apart each time. Healthcare staff provided patient water and monitored during event. Began to feel normal again as bp went down. HR stayed between 69-79 during entire time.

Worker received first dose of Pfizer at 13:20. Patient was observed for 15 minutes. During the time of her exit, observation provider noticed patient having a change in status and asked patient if she was okay. She stated that her "throat felt a little itchy."At that time observation provider escorted her into booth 11 for additional observation. She was assessed by NP who gave her Allegra at 1341. Lungs were clear. She began cough and Epipen was administered at around 1343 at the left thigh. Code blue was called as she appeared to be in distress. By the time code team came, patient was stable. IV started on left forearm and transported to Hospital ER and d/c. VSS-VS-130/81, HR 93, O2 100%

Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 03Feb2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension), depression, anxiety, RLS (Restless leg syndrome) and insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included lisinopril, trazodone, clozapine, pramipexole dihydrochloride (MIRAPEX), duloxetine hydrochloride (DULOXEE). The patient experienced severe fatigue, moderate nausea, mild diarrhea, severe headache, moderate muscle aches on 03Feb2021 10:00 with outcome of recovering. No treatment was received. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. Information on the lot/batch number has been requested.

Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.

chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.

my arm hurts; slight headache; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration in the right arm on 26Jan2021 at 14:45 ( at the age of 40-year-old) as a single dose for COVID-19 immunisation at workplace clinic. Medical history included penicillin allergy (childhood). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 27Jan2021, at 12:00 the patient experienced my arm hurts, slight headache and cold sweat and did not last long at all (as reported). The patient did not receive any treatment for the events. The events were reported as non-serious. The outcome of the events my arm hurts, slight headache and cold sweat was recovered on an unknown date in Jan2021. Information on the lot/batch number has been requested.

mild headache; mild bodyache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot: unknown) via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. Patient did not had Covid prior vaccination. Patient was not tested for Covid tested post vaccination. The patient experienced mild headache, mild body ache on 03Feb2021. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

12 hours after the second shot I had chills; followed by a low fever of 100.4 and body aches; followed by a low fever of 100.4 and body aches; This is spontaneous report from a contactable consumer (patient). An 40-year-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on left arm on 11Feb2021 12: 00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 on 21Jan2021 12:00 via unknown route on left arm single for Covid-19 immunization. The patient had no allergy. The patient not-receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient not received within 2 weeks of vaccination; Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. it was reported 12 hours after the second shot (11Feb2021) patient had chills. This was followed by a low fever of 100.4 and body aches. The chills and body aches continued for 24 hours until they subsided. Event duration was 24 hours. Patient not received treatment. The outcome of the events was recovered on 12Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

experienced a fast heartbeat/heart rate went up to the 160s; sweaty; dizzy; Heart threw a few PVCs; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in deltoid left on 22Jan2021 as 0.3 mL, single for covid-19 immunisation. Medical history included sensitive to drugs from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took celecoxib (CELEXA) and experienced ventricular extrasystoles, dicycloverine (BENTYL) and experienced ventricular extrasystoles and heart rate went up to 180 and blood pressure dropped. She has had this [premature ventricular contractions (PVCs)] occur a few times before, a history of it. Sometimes it occurs with medicines. Stated she is sensitive to drugs. Added, this occurred with Celexa, every 5-10 beats she would throw PVCs and it occurred until she was weaned off and stopped Celexa. The PVCs also occurred with Bentyl. When she took it her heart rate went up to 180 and her blood pressure dropped. She had to be taken by ambulance and was given fluids and she believes diphenhydramine (BENADRYL) and some other things, but she is not sure. The patient got her first COVID vaccine and experienced a fast heartbeat, felt sweaty and dizzy. She was wondering if what she experienced after the first shot a normal side effect and if it would be worse with the second dose. After the first COVID vaccine shot (after the ten-minute wait), her heart threw a few PVCs, her heart rate went up to the 160s, she was sweaty, and dizzy. She had to pull the car over. Stated she is worried about getting the second dose. Wondering if this reaction could be worse. Initially stated these events all resolved that same day, but then she followed up and clarified sometimes she still feels her heart throwing PVCs again. The patient stated she turned her car towards the Emergency Room (ER), but she ended up talking herself out of going. The patient underwent lab tests and procedures which included heart rate went up to the 160s on 22Jan2021 (fast heartbeat). The outcome of the event Premature ventricular contractions was not recovered while of the rest was recovered on an unspecified date.

body aches; prickly skin; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Intense pain at injection site and in right shoulder traveling down to elbow. Unable to raise arm overhead.; Chills; fatigue; general malaise; This is a spontaneous report from a contactable Other HCP, the patient. A 40-year-old non-pregnant female patient first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Lot Number: UNKNOWN), via an unspecified route of administration, in the right arm on 03Feb2021 at 12:00 PM (at the age of 40-years-old) as a single dose for COVID-19 vaccination. Medical history included patient was diagnosed with COVID-19 (prior to vaccination). Since the vaccination, the patient had not been tested for COVID-19.The patient had no Known allergies. Concomitant medications included multivitamin and magnesium supplement. On 03Feb2021 at 16:00 the patient expereinced Intense pain at injection site and traveling down to elbow. Unable to raise arm overhead. Chills, body aches, fatigue, prickly skin, general malaise. No treatment was received for the events. Outcome of the events were recovered on an unspecified date. Information on the lot/batch number has been requested.

Anaphylactic reaction including throat swelling, face, hand and feet swelling. Hives Tongue Swelling Syncope Lethargy Brain Fog ongoing Livedo reticularis on upper and lower arms and buttocks first started on 1/15/2021. I still have purple mottling over these areas that do not go away when warmed. The livedo reticularis is present at all times. Dyspnea and Tachycardia first started on approximately 1/20/2021 and has become progressively worse.

Tightness in the chest, warmth in the chest, blurred vision and sudden drop in blood pressure to the point of almost losing the consciousness, sweat, weak pulse. The symptoms appeared at about 4 mins after the injection in the resting area. The patient was taken on the wheelchair to lay down. The pressure was taken, the EkG. The ambulance cam after 20-30 mins. The patient started recovering but still felt tightness in the chest. The patient was taken to the Medical Center. The patient was given a blood test and urine test. The patient started feeling better and was sent home after about 3-4 hours.

1/19/2021 vaccination. Felt flu like symptoms, body aches, feverish. I reported to every day on health check-in. Muscle spasms, diarrhea, could not keep down water, HA, fatigue, lethargic. I thought I was dying. 1/21 0400am ER 1/22 ER 1/23 ER 1/24 ER; admitted inpatient to hospital. 11 Days inpatient. Nausea, vomiting, diarrhea, feverish, malaise, gastric spasms, HA, *12/2020 Gastrectomy *Symptoms lasted whole duration in hospital. Could not keep any liquids down.

dose 1: fever chills headache for about 3 days , tylenol taken dose 2: no fever, no tylenol taken, chills the first night, pain and swelling in neck and spine only at night for 2 nights , very slight headache, slight fatigue and nausea and weakness after naps, then fine by day 3 then suddenly this morning I had slight chest pain (pressure) and severe vertigo and fell in the bathroom, bp normal, temperature normal, spo2 nornal, normal hr, i had no choice but to report to work or i would lose my job (teaching in private school)

Seizure like events; Began sputtering; My shoulder and neck seized up; Eyes rolled back in her head and she had no control over it; Did not remember some of it; Confused; Unable to focus with her eyes; Extreme fatigue; Walking is unsteady; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: 59267-1000-03), via an unspecified route of administration, administered in left arm on 24Mar2021 16:45 as single dose for COVID-19 immunization. Medical history included asthma, bronchitis, anxiety, allergy to Aspirin, NSAIDs, agave, soy, and dairy. The patient has no history of COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not COVID tested post vaccination. Concomitant medications included venlafaxine and progesterone taken for an unspecified indication. On 24Mar2021, 19:30, the patient experienced seizure like events. She began sputtering, her shoulder and neck seized up, eyes rolled back in her head and she had no control over it and did not remember some of it. It happened twice in a row. She had been confused, unable to focus with her eyes, extreme fatigue, and her walking was unsteady. The adverse event resulted in Emergency room/department or urgent care. The patient received treatment for the events. The patient was requested for testing and referral for neurologist for MRI. The patient has not recovered from the events. Follow up attempts are possible. Further information is expected.

had swelling of cheeks, lips, cough , trouble swallowing about 30 minutes after vaccine administration

About 2-5 minutes after shot, I couldn?t swallow. My throat muscles just wouldn?t work, but it was really sporadic like once or twice every 30 seconds-2 minutes I was not able to swallow. After 30 minutes of no worsening and waiting at vaccine site, my throat became itchy on my drive home and i had to clear it often. Rarely this happens to me if I eat honeydew melon or drink soymilk. I went to Urgent Care, throat looked open and they told me to take Benadryl. I?m curious if you?ve had reports like this of sporadic throat inoperation and if it will happen worse with the second dose.

Body aches, chills, fatigue, headache, and eye pain for 24 hours. Arm soreness at the site for 3 days, followed by swelling and itch on entire upper arm where vaccinated. Swelling and itch lasted for 10 days.

Children said I would sit up say weird things then faint; dizzy; heavy eyes; heavy head; laid down do not remember anything from the evening; Children said I would sit up say weird things then faint; severe vertigo; confusion; shook uncontrollably for 30 minutes; This is a spontaneous report from a contactable consumer(patient). A 40-year-old non-pregnant female patient received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at 10 am (Batch/Lot Number: EN 6199) as single dose (at 40-year-old) in arm left for COVID-19 immunization. The patient wasn't pregnant at the time of vaccination. The patient had ongoing allergy to intravenous pethidine hydrochloride (DEMEROL). No other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL). Prior to vaccination, it's unknown if the patient was diagnosed with COVID 19. Since the vaccination, the patient hasn't been tested for COVID19. At 7pm the patient became incredibly dizzy, heavy eyes, heavy head, laid down did not remember anything from the evening. Children said she would sit up said weird things then faint. Laughed and shook uncontrollably for 30 minutes. Next morning severe vertigo, confusion. Went away the third day. No seriousness criteria reported. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the events. The outcomes of the events were resolving.

tiredness; arm pain; muscle weakness; intoxication; slurred speech; equilibrium off; feeling of euphoria; minor light head/dizziness/giddiness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), dose 1 via an unspecified route of administration, administered in left arm on 03Apr2021 09:30 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. 2 hours after shot (03Apr2021 11:30), minor light head/dizziness. 3 hours after shot (03Apr2021 12:30), slurred speech, equilibrium off, feeling of euphoria, giddiness, intoxication, overall felt amazing. 7 hours after shot (03Apr2021 16:30), tiredness, arm pain, muscle weakness. 24 hours after shot (04Apr2021 09:30) no arm pain, feeling normal, still feel a sense of euphoria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive ant list of any other medications within 2 weeks of vaccination. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no allergies to medications, food, or other products. There is no known allergies and other medical history. The outcome of the events was resolving.

At 1400, nausea and yea he started. By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness. VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor. Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021. Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.

throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5 during the 24 hours prior to my vaccination.

Diminished ovarian reserve/diminished reserve; fever; chills; hot flashes; nausea; vomiting; migraine headache; vertigo; weakness; They obtained an FSH level and it had skyrocketed from previous values not long before; my ovaries had shrunk in size by approximately half; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), first dose via intramuscular, administered in right arm on 19Dec2020 09:30 at a single dose (lot number and expiry date were not reported); and then received the second dose on 02Jan2021 09:30 (lot number and expiry date not reported), intramuscularly administered in right arm as a single dose; for COVID-19 immunisation. Medical history included eosinophilic esophagitis and asthma. The patient had no known allergies. The patient was not pregnant at the time of the report and vaccination. The patient had no covid prior vaccination. Concomitant medications which were taken in two weeks prior to vaccination included bupropion hydrochloride (WELLBUTRIN) and ethinylestradiol, norethisterone acetate (LOESTRIN), taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. On 19Dec2020, the patient experienced diminished ovarian reserve. Patient stated that she was extremely symptomatic after both vaccines and starting on 19Dec2020 had experienced fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness. The hot flashes persisted and worsened after each subsequent vaccine, prompting her to go to my MD. They obtained an FSH level on 19Dec2020 and it had skyrocketed from previous values (dates unspecified; unknown results) not long before. An ultrasound on 19Dec2020, showed that her ovaries had shrunk in size by approximately half and she had diminished reserve. Patient was now on supplemental hormones and will be for many years to come as she was only 40. Patient know the vaccine caused this. It was too great of a coincidence. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. As a result of the events reported patient was now on hormonal replacement therapy. The patient was tested for covid post vaccination which included nasal swab/Covid test on 14Mar2021 as negative. The outcome of the events reported was not recovered. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded, for events fever, chills, hot flashes, nausea, vomiting, migraine headache, vertigo and weakness, conversely the suspect drug is considered very unlikely related for other gynecological disturbances. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.

anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.

lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer. A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.

Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.

Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.

Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.

Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five days post COVID Pfizer vaccine. Symptoms strikes at random times. No prior health issues.

A few minutes after receiving her vaccine she reported dizziness and an itchy throat. She was observed for a few minutes and she stated that the dizziness was worse and that she felt flushed so she was given 0.3mg of IM epinephrine after which she began to immediately improve. She was also given 50mg PO diphenhydramine. She was observed for 60 minutes after the epinephrine dosing without any recurrence of her symptoms and she was discharged home with strict ER return precautions.

Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative

12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.

Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.

Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.

I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.

On the 21st in the morning I had alternating chills and subjective fever. I did not really have fever and kept monitoring it during the day. The next day I kept with the subjective fever and the chills, went to the urgent care the next day and was tested for covid, flu and strep and it came positive for strep. I was prescribed an antibiotic and stayed home the next day since I still did not feel well.

On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.

Severe fatigue; chills; headache; sore throat; muscle aches; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number not provided), via an unspecified route of administration in left arm on 23Dec2020 16:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe fatigue, chills, headache, sore throat, muscle aches on 24Dec2020. Case was non-serious. The patient underwent lab tests and procedures which included covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=26Dec2020, covid test result=Negative. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was recovering. Information on the lot/batch number has been requested.

after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to miss work

very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.

approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1 hour after vaccine she had a headache. I took her blood pressure, it was 158/83, Pulse 92, Respirations 20, not shortness of breath or respiratory difficulty noted. She laid down and continued to feel the same way after 2 hours post vaccination. Her husband picked her up and she went home to rest for the day. She was given instructions on when to seek medical attention and to call me later today to let me know how she is feeling.

got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.

hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks. Medical history included allergies to penicillin and shrimp. There were no concomitant medications. The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; whole body muscle aches; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (batch/lot number and expiration date not provided, not available/provided to reporter at the time of report completion), via an unspecified route of administration, at arm left, first dose on 23Dec2020 09:15, at single dose, for COVID-19 immunization. No relevant medical history. No known allergies to medications, food, or other products. There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme chills, extreme fatigue and tiredness, whole body muscle aches, slight shortness of breath all lasting over 1 week, all from 23Dec2020 16:15. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (test type: Nasal Swab, test name: rapid test): negative, on both 27Dec2020 and 30Dec2020. The outcome of the events was not recovered. Information about Batch/Lot number has been requested.

vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional . A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital. Medical history included seasonal allergy. No known allergies to medication, food or other products. The patient's concomitant medications were not reported. On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14. Information about lot/batch number has been requested.

24 hours post-vax woke with severe dizziness severe, fatigue, and muscle aches. Fever from 12/21 -12/22 21, peak temp 102.9. However, I am breastfeeding and suspect I may have had mastitus. Took measures to hydrate and express milk to ensure that was treated. Spoke to NP in the ER unit, did not take prescribed meds since fever broke.

24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl

Approximately 36 hours post 2nd dose of vaccine I experienced intermittent fever and severe chills (rigors) over a 6 hour period not relieved by ibuprofen; tmax 103. All symptoms resolved by the 48 hour post vaccine mark

Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.

Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain

Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction

Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.

Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was intoxicated. this passed after a few hours. Narrative: Employee missed greater than >1 days of work second to symptoms (aches and extreme fatigue)

fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side

site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl

tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.

woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.

Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.

About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.

Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.

Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 02Jan2021 08:00 to 02Jan2021 08:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jan2021 03:30, the patient experienced fever, chills, vomiting, and diarrhea. The patient underwent lab tests and procedures which included Sars-cov-2 (Nasal Swab) test on Jan2021: with negative result post vaccination. The outcome of the events was recovering. No treatment was given for the events. No follow-up attempts are possible, information about batch number cannot be obtained.

Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.

Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.

Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.

Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, localized discomfort

Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), via an unspecified route of administration on 23Dec2020 07:00 at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient previously took oxycontin and experienced allergies. Concomitant medications included women multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced random heart palpitations, tachycardia, mild chest tightness and occasional fatigue five days after receiving the vaccine on 28Dec2020 12:00. No known underlying health issues before the vaccine. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events resulted in Emergency room/department or urgent care.

Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills

Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue

Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8). 1/7 morning: body aches, chills, feelings of unwell. Unsure of fever as she has been rotating Tylenol and motrin. EE reports she saw RN at campus this morning for inspection of injection site. Home remedies? - ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin. EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns. EE denied history of COVID-19 exposure without proper PPE and denied recent travel. EE educated to manange per Illness in the Workplace Policy. EE encouraged to fill out V-safe. EE verbalized back understanding and denied further questions at this time.

chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.

felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; nausea; Since then, it just doesn't feel right; since the vaccine have stiffness when turning my neck; a few headaches; This is a spontaneous report from a contactable nurse (patient) A 41-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 21-DEC-2020 09:30 (at the age of 41-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Soon after receiving the vaccine in my right arm, she felt a strange feeling in the right-side of the neck that ended around the base of the head and nausea on 21Dec2020. Since then, it just doesn't feel right and still have the nausea and since the vaccine have stiffness when turning my neck on 21Dec2020. "I can't really describe it much more than it feels strange and hasn't gotten better". The patient had a few headaches on 21Dec2020 but am unsure if that's related to the vaccine as they didn't occur immediately after receiving it. The events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches was recovering. Since the vaccination, the patient has not been tested for COVID-19.

2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.

Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-vac, duration: 1.5 days) Fatigue (start: ~24 hrs post-vac, duration: 1 day) Joint & Muscle pain (start : ~24 hrs post-vac, duration: 1 day) Headache (start ~24 hrs post-vac, duration: 8-12 hrs) Armpit/upper breast pain (start ~48 hrs post-vac, duration: 2 days)

Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.

Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released

Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches

Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.

employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.

HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55PM PATIENT STATED SHE IS NOT GETTING WORSE @1:26PM PATIENT REFUSED EMERGENCY SERVICES AND/ OR CALLING MD

I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12/29/2020. I started feeling unwell on 12/31/20. On 1/1/2021, chills and body aches started for two days. I continue to have daily headaches and off and on chills and body aches. Other symptoms are congestion, running nose and diarrhea.

Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme fatigue and headaches 2 days, normal fatigue and nausea about a week.

Nausea, headache, fatigue, muscle aches, fever (100.3) fever day one and 3. Headache muscle ache nausea and fatigue everyday so far.

fever of 101F that began approximately 12 hours after vaccine administration and lasted less than 24 hours.

12 hours after the inj had chills, myalgia, headache low grade fever and nausea. Developed pain in external genitalia, Had ulcerations with bruising on 1/9/21. (Lesions)

I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer covid19 vaccine. Chills lasted for about 15min, they were of moderate intensity. Then I had low grade fever, body ache and tiredness for the entire next day (01/08/2021); it was bad enough to interfere with my regular activities of work and childcare. I ended up taking the day off. On the following day (01/09/2021), I woke up fully restored.

Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following morning, I had fever of 101.4F. I also had bad headache and muscle aches. I tool 500 mg of Tylenol, had lots of fluids and rest for 2 days. Sunday when I woke up I felt better and I feel well now.

Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain

On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/20, the shortness of breath worsened, developed muscle aches, headache and fatigue continues, blood pressure became elevated. Was seen in the Emergency Room. On 1/11/20 was evaluated by Primary Care Provider. Blood pressure medications were increased and taken off work until stable.

Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.

cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to throat leading to difficulty swallowing

2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.

41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell. Patient's initial symptoms started on 1/8/2021 with some rhinorrhea. The following day on 1/9/2021 she went to the gym feeling fine. That evening she felt fatigued and attributed to her workout earlier in the day. The next day she developed a severe headache with fever, sweats, chills and body aches. Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms. Patient presented to the office today on 1/12/2021 for testing and was Covid positive. Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell. At that time the duration of her symptoms was 3 days. She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness. She had the second Pfizer Covid vaccine on 1/8/2021. Patient works in administration of a medical facility. She has minimal contact with clinical staff and patients. No one in her office has had Covid symptoms or infection. Patient's other contacts are at home and the gym. She does attend a gym class with 10 other participants. She does not know whether anyone in the gym class has had symptoms.

Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but definitely uncomfortable) over next few hours. Finally tried 2 puffs of my son?s albuterol about 5 hrs post vaccine and felt relief within 20?30 minutes. The next day I had more expected side effects: headache, myalgias, chills and fatigue. No recurrence of the chest symptoms.

Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm

Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.

Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.

Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .

Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.

Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Benadryl 25 mg po given at 8:40 and manager called to take her from work due to Benadryl

Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.

a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome. Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events. Information about Lot/Batch number is requested.

24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.

Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Benadryl routinely and Prednisone 10mg daily for three days with resolution of symptoms. Patient has a history of hives after flu vaccine, antibiotics, and childhood vaccines. Had second COVID vaccine 1/12/21. Developed hives on neck, arms, chest, and back. Also had a mild headache and nausea on 1/12/21 which have resolved. Is again taking Prednisone and Benadryl. Patient did not seek medical help. She has Prednisone on hand for these reactions since they are common for her.

Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.

Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.

So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 hrs later, nausea, numbness, body aches, joint pain, headache and fatigue.

Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had body ache. It progressed from there then I tested positive for Covid. I went to a clinic to get tested was given Zpac, Zythrimac, steroids' .

developed a scratchy throat at 2100 and by 2130 felt like throat was tightening. Went to ER and received Benedryl 50 mg IV, Solu medrol IV and protonix IVPB.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain

10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.

1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.

Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache, dull neck pain that extended all the way down to my left foot and left arm soreness. She noticed facial droop on the left side at which case, she decided to sleep it off. When she woke up the following morning, She still had a slight droop but not as noticeable. Symptoms disappeared approximately 24 -30 hours post injection.

Employee stated that she experienced a panic attack while on duty the same day she received the vaccine - approximately 12 hours after administration. She has a history of panic attacks, especially when she is fatigued - which she states she was that day. She also reported that her friends brought her a double expreso coffee approximately 1 1/2 hours before attack. She went to the ED where she was released home.

Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.

Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days post injection. Remaining enlarged still a week later. Fatigue as well.

Headache, Fatigue -30 min after (gone at 37 hours) Muscle Aches - 27 hrs after (gone at 37 hours) Eyelid edema & swelling in fingers - 37 hours (gone 72 hours)

I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.

My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches. Consulted with my PCP who suggested a mammogram and an ultrasound. Both done at Hospital. It shows lymph nodes are swollen and a follow up appointment has been schedule for 3 months. If they are still swollen a biopsy will be made.

Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.

Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.

Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.

Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.

Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted for 1 day

not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable Pharmacist (patient). This 41-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140), via an unspecified route of administration, on 06Jan2021 at 01:30 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at hospital, age at vaccination was 41-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included sambucus nigra (ELDERBERRY), colecalciferol (VITAMIN D), camellia sinensis (GREEN TEA). On 08Jan2021 at 12:00 AM, the patient experienced nausea, diarrhea, chills, not feeling well overall. The events were reported as non-serious. The patient was tested for Covid post vaccination however it was also reported that she was not tested (to be clarified). Outcome was recovering. No treatment was received for the events.

right side between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue will monitor and report to PCP if needed

sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .

took a rapid test and it came up positive; took a rapid test and it came up positive; fever 100.8; coughing; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, reported as Pfizer covid19 el1284), via an unspecified route of administration on 30Dec2020 14:30 in left arm at single dose for covid-19 immunisation. Medical history included asthma and arthritis. Concomitant medication included ibuprofen and paracetamol (TYLENOL). The most recent COVID-19 vaccine was administered in public health clinic/ veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient got the vaccine on Wednesday 30Dec2020, and by Saturday (02Jan2021 22:30) she started with a little coughing that increase on Monday (04Jan2021), Monday afternoon she had fever 100.8. She thought she was experiencing side effects and reported to her supervisor and didn't work the 2 next days. She when back to work on Thursday (07Jan2021), she was sent to a covid clinic and took a rapid test and it came up positive. The patient underwent lab tests and procedures which included nasal swab (rapid antigen testing - SARS-CoV-2): positive on 07Jan2021. The events were reported as non-serious. No treatment was received for the events. Outcome of events were recovering. Information on the lot/batch number has been requested.

About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.

Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain

Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.

Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.

Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)

Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.

Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.

I had common side effects of cough/sneezing for 24-48 hours. I was 20 days post-op double mastectomy with DIEP reconstruction. Although we knew I?d have side effects that would out weigh me getting the virus, we didn?t think ahead of that. My adverse event is that I ended up with a hernia in my lower left stomach. I have a bulge and some pain. My surgeon will be able to fix it after 3 months post-op.

I vomited several times; Severe headache; Muscle aches; Chills; Joint pain; Tiredness; Fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration from 07Jan2021 10:00 at left arm, at single dose for covid-19 immunization. Medical history included COVID 19 positive 12Dec2020, the patient was diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was reported no. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient received vaccine at 07Han2021 10:00PM (as reported). 4 hours after receiving the vaccine 07Jan2021 14:00 the patient vomited several times, the patient had and still have severe headache, muscle aches, chills, joint pain, tiredness and fever. The patient realized that these are side effects and not adverse reactions but she felt that they were quite severe and she thought it was due to the fact that she so recently had COVID 19. OTC meds were received for all events. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.

Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.

Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), via an unspecified route of administration in the left arm on 08Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included migraine and seasonal allergies. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medications included melatonin and levocetirizine dihydrochloride (XYZAL). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular in the left arm on 18Dec2020 at the age of 41-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 08Jan2021 09:30, the patient experienced nausea, dizziness, fever. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.

On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.

Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. As day progressed, fatigue, joint pain, mm aches increased. Fatigue, headache, injection site pain and swelling, new or worsened joint and muscle pain

Staff had 2nd vaccine yesterday 01/13/2021 at 11:20. At night 3 am woke up with bodyache, lower back pain, fever 103, could not sleep. Took Tylenol. Today at 12 noon staff feels chill, fever 102. Now ok. W

Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.

Within 12 hours of receiving second dose of Pfizer COVID-19 vaccine, patient developed fever 39.5, chills, body aches and headache. Tylenol and ibuprofen did not help with fever much. No notes on further escalation of care or resolution.

Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.

~15 minutes post vaccination, reported feeling sensation on right side of throat. Tightness, burning, swollen ("like strep throat, raw") 1515: Dose of 50mg capsule of diphenhydramine PO Can swallow without difficulties Denies troubles breathing 15:25: Notes some improvement in symptoms, denies worsening VS: 148/98

Fever (max 102.5), chills, sweats, headache, muscle pain, fatigue. Fever started 13 hours after injection. I am now 29 hours post-injection, and fever (as well as all other symposiums) persists.

I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.

Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprofen and 25 mg of benedryl then went to bed (after working night shift). Upon waking around 4pm the numbness was gone

1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted for 25mg Benadryl as a precaution. BP 112/72. Reported itchy back. Checked back, unremarkable. 3:30, no issue ? she went home. F/u 4:30 - no issues

Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.

Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.

5 minutes after vaccine- hot/dizzy, lasted less than 1 minute. Right side neck pain/ache, left arm pain/ache- lasted less than 5 minutes. 30 minutes after vaccine rash, itching- lasted 2 days. 1 hour after vaccine- severe headache lasted 4 days. 4 hours after vaccine- ears/throat itching. Took Benadryl 50mg, Tylenol 1000mg, Albuterol Inhaler 2 puffs, and Famotidine 20 mg 4 hrs after vaccine.

Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Fever of 102-103 F. Nausea, Vomiting, weakness, cough and post nasal drip. Inflammation of lymph nodes left upper extremity , head and neck. Began to feel difficulty swelling due to inflamed lymph nodes Treatment: Intravenous fluids, anti-inflammatory medication, sought treatment at an urgent care center. Ultrasound of left arm, axillary and neck and chest area for enlarged lymph nodes. Outcome- all symptoms resolved by 1/14 except some fatigue

Had sore arm quickly after Chills 24hours after 30 hours after woke up with serve left side jaw pain into cheekbone and facial swelling on left side of face. Sunday called my employee health who sent me to ER. Given steroids for 4 days for swelling and pain to left cheekbone and jaw area (especially at the joint) noted mild left side throat swelling on exam (internal)

I became very weak, lethargic, vomiting, sore...flu like symptoms. Sent home. Lasted for two to three days. I was told that if symptoms got worse to go to ER, but they started getting better with time.

I developed lightheadedness within 2 minutes of receiving covid 19 vaccine. I did not faint. I developed labored breathing around the same time as the lightheadedness. I was evaluated in the emergency room and diagnosed with a vasovagal event. The evening of the vaccine, I developed mild body aches, especially in the legs. The morning after the vaccine, I developed headache ,nausea and vomited once.

Soreness/pain in the injection site starting 3pm on January 8, 2021 until January 10 at 11am. I cannot lift the affected arm but still can do light activities like eating, writing, typing, etc. Chills and fatigue starts saturday January 9 at 7pm until January 10 at 11pm. I took tylenol starting January 8 for the pain until pain is gone and took Theraflu starting January 9 until sunday bedtime at 11pm. Bedrest and increase fluid intake one of the interventions, besides medicines.

Started with aches, pain and headache on 1/14 pm. By 1/15 am temperature had spiked to 106 but was responsive to acetaminophen and remained high until 1/17 am. patient is continuing to experience aches and pain still 1/18. Face was swollen and red until 1-17 pm. Lymph nodes in neck, collar bone and armpit on right side were swollen and sore. About 3 inches below actual injection site an area 1x2 inches is red and hot to touch still on 1/18

Teeth chattering but not cold or feverish Feeling there was movement within my head that a piece of the brain was moving up and down like my mouth (not dizzy or felt like room spinning) Feeling there was darkness/stuffiness in my head (not congestion) Feeling like my brain was not in control of my body Feeling sluggish The chattering lasted less than a minute, the motion in the head has weakened but still present and the darkness in the head is gone.

tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

At about 4:30am on 12/24/20 she woke up with an itchy throat and hives all over body. Took 50mg Benadryl and symptoms cleared up in 3 hours. Developed hives again that evening. Took Benadryl 25mg and resolved. This has continued to occur approximately once daily with relief of Benadryl 25mg. Was advised by Dr. that this could be from an allergy to the filler.

Developed fatigue, low grade fever and body aches approximately 10-12 hours following vaccine. Symptoms persisted for 12-14 hours and subsided following dose of ibuprofen 800mg.

Developed nausea 1-2 hours after vaccine. Developed mild muscle aches and cramps later that day. Symptoms gone by next day except residual site soreness. Asthma has worsened and is using Albuterol inhaler 1-2 times daily since second dose. Woke up 1/19/21 at 3am. Developed temperature then was diaphoretic. Vomited. Developed SOB, tachycardia, and wheezing.

Got vaccine on 1/16/2021 at 8:03 am only had left arm pain site of vaccine given later in the day started having Headache, Body aches, Fever, Fatigue. Sunday 1/17/2021 left arm pain where vaccine given, headache, fatigue, minor body aches. Monday 1/18/2021 only headache, fatigue, minor left arm pain where vaccine given.

Mild skin rash/welts on face. 1cm sized itchy swelling on bottom lip. puffy eyes (mild) mildly scratchy thoat. Mildly scratchy eyes. Was better by morning and gone by the next evening. Did not take Benadryl.

Patient reports left side facial drooping, weakness, headache. Patient states symptoms have resolved. Patient referred to her PCP to discuss whether she should get her second dose.

Roughly 2-3 minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off to breath properly. ( I did not remove my mask) My heart then started to race and I felt a warming, tingling feeling throughout my body. I felt a little hot and light headed. I stayed sitting in my chair, tried to take some deep breath, and everything went away. This lasted about 30 to 60 seconds. I did NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone. I stayed for about 15-20 minutes post injection and then I left and drove home. I did feel tired and my arm is sore at injection site, but other than that, no other effects.

Within 2 hrs- blurred vision, dizziness, sore arm Within 4hrs- tachycardia, lightheaded, headache, fatigue Within 6hrs- headache, extreme fatigue, SOB Within 8hrs- tightness in chest, extreme fatigue, body aches, chills plus all others listed

muscle aches; headache; soreness on left arm; felt cold in the evening of 08Jan2021; feels like having a fever/fever of 101.4F; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK9231, unknown expiration), via an unspecified route of administration in left arm, on 08Jan2021 at 09:15, at single dose, for COVID-19 immunization. Medical history included palpitations and COVID-19 on 26Mar2020 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). On 26Mar2020, the patient had nasal swab for COVID-19 which is positive. The patient has no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VIT C), metoprolol, and unspecified multivitamins. The patient felt cold in the evening of 08Jan2021 at 20:00, feels like having a fever. The next morning (09Jan2021), the patient had a fever of 101.4F, muscle aches, headache and soreness on left arm. The patient took Tylenol, lots of fluids and bed rest. The patient started feeling better on 10Jan2021. COVID-19 vaccine was administered in a hospital. The patient is not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On unspecified date, the patient was tested for COVID post vaccination (COVID-19 PCR) with unknown result. The patient did not receive other vaccine in four weeks. The patient recovered from the events in Jan2021.

muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about Lot/Batch has been requested.

severe chills; severe nausea (no vomiting); headache; neck aches; This is a spontaneous report from a contactable physician (reported for herself). A 41-year-old female patient (Pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3248), via an unspecified route of administration on 10Jan2021 08:30 at single dose for COVID-19 immunization. The patient's medical history included Allergies to amoxicillin. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (lot number: ek9231) on 22Dec2020 21:45 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe chills, severe nausea (no vomiting), neck aches, headache on 10Jan2021 20:30. Treatment received for the adverse events included tylenol 1g x3 doses. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Jan2021.

Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional nausea throughout the day and fatigue.

Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.

sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left deltoid, on 09Jan2021 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and COVID-19. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included amlodipine besilate (NORVASC), ascorbic acid (vitamin C; MANUFACTURER UNKNOWN), ergocalciferol (reported as: vitamin D; MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), and magnesium (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified daily multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in left arm, on 19Dec2020 at 07:00 (at the age of 41-years-old) for COVID-19 immunization and experienced sore left deltoid (Day 1), body aches (Day 1), headache (HA) (Day 1, 2, & 3), all over body aches (Day 2), fatigue (Day 2, 3, & 4), chills (Day 2), myalgia/muscle ache (Day 3), all over joint pain (Day 3), lower/upper extremity (LUE) pain (Day 4), and muscle and bone pain (Day 4). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore left deltoid, mild muscle aches, mild neck/joint pain, and tired on 09Jan2021. The events were reported as non-serious. The events occurred on day 1 after vaccination and by day 2, the patient felt great with no side effects. Therapeutic measures were taken as a result of all of the events, which included paracetamol (TYLENOL) and ibuprofen (MOTRIN). The clinical outcome of sore left deltoid, mild muscle aches, mild neck/joint pain, and tired was recovered on 10Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Chills; Headache; Site pain; Body ache; This is a Spontaneous report from a contactable Nurse (patient). A 41-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 09Jan2021 08:45 (lot number EL0142) at the second single dose, intramuscular on 21Dec2020 11:15 (lot number EH9899) at the first single dose for covid-19 immunisation. Anatomical location was left arm. Medical history reported as none. The patient's concomitant medications were not reported. The patient experienced chills, headache, site pain, body ache on 09Jan2021 21:00. The patient underwent lab tests and procedures which included Covid testing viral RNA: negative on 04Jun2020 via Nasal Swab. The outcome of events was unknown.No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination

Employee developed muscle aches and pains, fever, extreme fatigue, called off work 4 days. Continues to have moderate-severe leg pain as of 1/20/21. Tylenol brings pain from moderate to mild.

Headache for the entire day; Malaise; Fatigue; Body aches; Vivid dreams (fever); Vivid dreams (fever); This is a spontaneous report from a contactable nurse. This 41-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Ej1685), via unspecified route at left arm on 17Dec2020 07:30 PM at single dose for COVID-19 immunization. Medical history included Insomnia and obesity. No known allergies. No other vaccine in four weeks. Concomitant medications included zolpidem tartrate (AMBIEN), acetaminophen, acetylsalicylic acid (ASPIRIN) and diphenhydramine. On 08Jan2021, patient experienced headache for the entire day, malaise and fatigue, body aches and vivid dreams (fever), all with outcome of recovered in Jan2021. No treatment was received. No COVID prior vaccination. No COVID tested post vaccination.

I have had a severe headache since the day of vaccination, weakness, fatigue, dizziness, vomiting and diarrhea.

LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; body aches/all over body aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), intramuscular on 19Dec2020 07:00 am at single dose at left arm for covid-19 immunization. Medical history included hypertension, covid-19 (prior vaccination). No known allergies. Concomitant medications in two weeks included amlodipine besilate (NORVASC), ascorbic acid (VIT C), ergocalciferol (VIT D), magnesium chloride (MAG), zinc and daily multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced sore left deltoid, body aches, headache all on 19Dec2020 16:00, all over body aches, headache, fatigue and chills all on 20Dec2020, mialgia/muscle aches, fatigue, headache and all over joint pain all on 21Dec2020, headache, LUE pain, muscle and bone pain, fatigue all on 22Dec2020, patient finally felt better with decreased symptoms on 23Dec2020. Outcome of all events was recovered on unspecified date. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient received paracetamol (TYLENOL), motrin for events.

Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching in her upper body and in legs, like a rash; Mottled skin; This is a spontaneous report from a contactable nurse reporting for herself A 41-years-old female patient received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm on 11Jan2021 13:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient experienced really bad headache on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a rash on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown. Unknown treatment was given for really bad headache The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Sudden onset of tachycardia 220 beats, faint, week, sweating, clammy, hot, cold, dry heaving, feeling like going to pass out

general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.

hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

itching; palpitations; back ache; had an allergic reaction; full blown hives; rash on her face, ears, legs and arms; fever; tired; sore throat; swollen lymph nodes; chills; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685, expiry: Mar2021) intramuscularly on 19Dec2020 at a single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. On 20Dec2020, the patient experienced fever, tired, sore throat, swollen lymph nodes and chills. On 08Jan2021, the patient experienced rash on her face, ears, legs and arms. On 09Jan2021, the patient had an allergic reaction and had full blown hives. It was also reported that the patient experienced itching and back ache on an unspecified date. The patient also experienced palpitation on an unspecified date and she went to the emergency room in which she was prescribed with lorazepam (ATIVAN). The patient was also treated with naproxen (ALEVE) for fever and back ache, steroid (unspecified) for allergic reaction and hives, TRIAMCINOLONE cream for the rash and HYDROXYZINE for the itching. Outcome of the events fever, tired, sore throat, swollen lymph nodes and chills recovered on 21Dec2020 while for the events full blown hives, itching, had an allergic reaction, rash on her face, ears, legs and arms, palpitations and back ache was unknown.

states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the vaccine clinic, and then escorted to the ED -states the ED observed until sx dec - was told she had a catacholemine response, states is feeling fatigued

tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.

Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injection site, started with adverse symptoms, still having & redness is getting larger now (55 hours after injection)

I experienced mild to moderate headaches. I felt very fatigued. I still have mild to moderate headaches today.

I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle pain, also pain at the injection site. i felt very tired. The next day I had severe headaches, muscle pain and fatigue and took Ibuprofen as pain medication. My headache went from a severe to moderate. All the rest of days continued with headaches.

Immediate nausea and dizziness followed by increasing fatigue, brain fog and cognitive difficulties (I.e. driving and returning to work after) especially involving quick movements, tracking and concentrating. Moderate Arm soreness increased from the time of shot continuing beyond 24 hours and making it difficult to lift or move the arm

Pt began to feel tingling around mouth area and throat started feeling thick but not closing. Patient had her own personal Benadryl on hand and administer 50 mg orally to self. Pt was watched for 20 minutes by EMT following administration- she reported her throat continued to feel scratchy. Patient was driven and advised to go to emergency room. hospital was contacted per EMT and informed that patient was in route to hospital following a reaction to COVID-19 vaccine.

Same symptoms as when I actually had covid mid December. Headache, back ache, fever, chills, body aches

About 17 hours after receiving the vaccination, I had vertigo. I woke up at 4:30 AM half an hour before my usual wake-up time, and the room was spinning and I had a headache. I had nausea at the time. I was unsteady for about 30-60 minutes, until I took Dramamine, which resolved the issue that day. Then about 24 hours after I received the vaccination, I developed chills and fatigue ( I didn't check by temp). I have been having vertigo daily and a headache upon waking up in the morning (today is 5 days post vaccination), and today, this was associated with an episode of emesis without nausea or abdominal pain. I did not have these issues previously.

Felt dizzy and light headed immediately following injection Had flu like symptoms from 1pm through 9pm I took 1,000 mg Tylenol at 5pm Developed generalized, all over body severe itchiness at 9pm Took Benadryl at 11:45pm Woke at 6:00am on 1/23/21 with continued all over body itchiness, although more mild/moderate Reporting at 6:55am on 1/23/21

For informational purposes, to hopefully add to current research:. Dose 1: administered in the am-lightheaded, tired, sleepy began after an hr or so after administration and continued throughout the day, blood pressure increased significantly after a few hrs (151/94); was much better the following day, only feeling tired and having pain at site of vaccine/upper arm. Dose 2: administered in the pm- lightheaded slightly for the first hr, more dizzy after 2.5 hrs, blood pressure ok, but severe headache; woke up with chills 2-3x that night, woke up with headache still, no fever, joints aching more than usual in spite of taking lots of ibuprofen; slight upper arm pain. Headaches have continued and my typical joint/back pains seem to be a lot worst and not really responding to ibuprofen. May be coincidence, maybe not. Thank you.

I awoke in the very early morning hours today, January 23, not able to sleep. My head, neck, and body were pounding. I feel achy as if I have the flu. My nose is stuffy, much more congested than it has been.

Chills, fever, swelling in face where facial filler had been - this is the worst and most continuous adverse effect now three full days later

Initially felt some anterior cervical lymphadenopathy Difficult to sleep that night due to muscle aches, had to continuously stretch in bed, headache, some nasal congestion (resolved quickly), muscle aches continued in the morning but worsened around 11:30am on 1/24 and developed fever to 100.9. Muscle aches and fever lasted until taking Tylenol a few hours later.

L arm pain and swelling at injection site. Upper body aches unable to sleep. Lasted about 12-15 hours was gone about 27 hours after injection. Fatigue and feeling flush then chilled very mild. No fever

Day 1: Moderate Headache, chills, low fever, moderate joint pain and body ache, and injection site pain and swelling Day 2: chills, low fever, moderate to severe joint pain and injection site pain, severe fatigue Day 3: mild to moderate joint pain, mild to moderate body ache, moderate to severe fatigue, malaise Day 4: moderate to severe fatigue, malaise, mild body ache Day 5: moderate fatigue, malaise, mild body ache Day 6: moderate fatigue, malaise, mild body ache

Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.

Headache at about 20 minutes post shot. Took ibuprofen it worsened over the next hour. When that wore of off headache returned low throb this time. Mostly in the front. A low grade fever appeared.

I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the injection site about 6 hours after receiving my vaccine. The next morning, about 18 hours after receiving the vaccine the injection site redness had extended to about 2" and had become painful. At about 22 hours after injection I began having a significant headache, chills, elevated temperature of 100 degrees, body aches, exhaustion and overall unwell feeling. This feeling persisted through the remainder of the day. By 46 hours post vaccination the redness and swelling had grown to about 3" and now had a strong red center, was hot and hard to the touch. I was still having chills, temperature stayed around 99 degrees, still felt tired and had headache. At about 66 hours post injection I have sinus congestion and the swelling and redness at the injection site is about 3 1/2" and swelling without redness now extends about 2" past the redness down my arm.

I had chills, severe body aches, head ache, weakness, fever of 100.5. Symptoms lasted around 36 hours.

Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.

body aches, headache, nausea, vomiting, fever, chills, elevated pulse, generalized weakness and dizziness. Pain to left arm

following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.

About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.

Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.

Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing. This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.

Initially a general ill feeling and then pain in the hip joint.; Initially a general ill feeling and then pain in the hip joint.; This is a spontaneous report from a contactable consumer. A 41-year-old female patient (NOT PREGNANT) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in Jan2021, via unknown route of administration at single dose (second dose); via unknown route of administration at single dose (first dose) in Jan2021 for unknown indication. Medical history and concomitant medications were unknown. There were unknown allergies. There was unknown if patient received other vaccine in four weeks and Other medications in two weeks. Patient experienced initially a general ill feeling and then pain in the hip joint in Jan2021. Patient did not receive any treatment. Patient did not have COVID prior vaccination and COVID tested was unknown post vaccination. The outcome of the events was recovered in Jan2021. Information on the Lot/Batch Number has been requested.

My heart was pounding so hard that it woke me up. My Oura ring was able to record the elevation in my heart rate. I went from the 50's in a dead sleep to the 80's between 7-8am. Otherwise I had general lethargy, fatigue, and arm soreness. I did not have a fever.

Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4. Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.

aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), intramuscular on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), fexofenadine hydrochloride (ALLEGRA). The patient had first dose of COVID-19 vaccine on 21Dec2020 intramuscular at right arm. On 12Jan2021, the patient experienced aches, muscle pain, low grade fever, and enlarged lymphnodes left supraclavicular region. The outcome of the events was recovering. The patient did not receive treatment for the events.

could not get up from the bed; she did not feel well; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for prevent COVID on 18Dec2020 at 07:00am, at 41-year-old. Medical history included: seizures from 2014. Concomitant medication included: ongoing topiramate oral 50mg one tablet in the morning and two tablets in the evening for seizures; levetiracetam (KEPPRA). No additional vaccines administered on same date of BNT162B2. She was okay on 19Dec2020. After mid-day around noon (19Dec2020) she did not feel well, and it was hard for her to work on the 19th. She missed two days of work. On 20Dec2020 she could not get up from the bed. Emergency Room or Physician Office not visited. No relevant tests done. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown. Information about lot/batch number has been requested.

headache; feeling unwell; received the first dose on 18Dec2020 injection in left arm at 07:00am/ second dose on 11Jan2021 at 15:30; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, in the left arm on 11Jan2021 at 15:30, at a single dose, for COVID-19 immunisation (prevent COVID). Relevant medical history included seizures diagnosed in 2014. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) injection on 18Dec2020 at 07:00 A.M. in the left arm for COVID-19 immunisation (prevent COVID). She was ok on 19Dec2020. After mid-day around noon she did not feel well, and it was hard for her to work on the 19th. She missed two days of work. On 20Dec2020, she could not get up from the bed. Concomitant medications included topiramate for seizures and levetiracetam (KEPPRA). The patient did not receive other vaccines within four weeks prior to and on the same day of COVID vaccination. The vaccine was administered in the hospital. The patient received the COVID vaccine yesterday (11Jan2021). She missed work today (12Jan2021) since she was feeling unwell and having a headache. She works in housekeeping. She started feeling unwell and her headache started after 3 in the morning. She wanted to stay home. Last night she was quite unwell, but she was better after taking second dose of Tylenol. She may need to take more medicine in 2 hours. The events did not require emergency room or physician visit. She does not have lot, NDC, or expiration date to provide for either dose. Outcome of the events headache and feeling unwell was recovering. Information about lot/batch number has been requested.

menstrual cycle started 4 days early with heavier than usual flow; Myalgias; Chills; Tmax 100.7; This is a spontaneous report from a contactable physician reported for herself. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142), intramuscular in the right arm on 08Jan2021, 15:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have Covid prior to vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included multivitamin. The patient previously took amoxicillin and experienced hypersensitivity (reported as known allergies to amoxicillin). The patient received the first dose of bnt162b2 (lot:EK5730), intramuscularly in the right arm on 18Dec2020 at 11:00AM at a single dose for covid-19 immunization. The patient experienced myalgias, chills, tmax 100.7 on 09Jan2021 09:00. It was also reported that patient's menstrual cycle started 4 days early with heavier than usual flow on 09Jan2021 11:00. Patient did not received treatment for the events. The outcome of the event myalgia, chills and pyrexia, was recovered on 09Jan2021, 21:00 and recovered on an unknown date for the event menstrual cycle abnormal. Patient was not tested positive for Covid-19 post vaccination.

After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my whole body. I had the chills and a headache as well as muscle aches and a sore throat. After the second dose I had the chills again, headache, fever, sore throat, severe fatigue, muscle aches, runny nose that lasted over 24 hours.

Chills; sweats; headache; myalgia; fatigue; This is a spontaneous report from a contactable other hcp reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at right arm on 11Jan2021 09:00 AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination, no COVID tested post vaccination. No other vaccine in four weeks. NO other medications in two weeks. Patient received first dose of BNT162B2 (lot number= EJ1685) at right arm on 20Dec2020 07:15 PM. On 11Jan2021 08:30 PM, the patient experienced Chills, sweats, headache, myalgia, fatigue. No treatment received. The event outcome was recovered.

Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Starting from 12 hours after receiving the second dose of Covid vaccine, I?m experiencing palpitations, fatigue, muscle pain and dizziness. I took Tylenol and felt better

headache runny nose Nausea severe muscle aches fever 102 degrees chills muscle fatigue shortness of breath cough congestion

weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.

15hrs post injection, muscle aches, joint pain; 15hrs post injection, muscle aches, joint pain; injection site pain 12hrs post injection; intense chills/shivering 12hrs post injection #2; This is a spontaneous report from a contactable nurse. A 41-year-old non-pregnant female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3248 and Expiration Date: Apr2021), via an unspecified route of administration in the left arm on 15Jan2021 at 12:00 at 41-years-old at a single dose for COVID-19 immunization in a hospital. Medical history included asthma from an unknown date and unknown if ongoing, gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing, thoracic outlet syndrome (arterial/neurogenic) from an unknown date and unknown if ongoing, Allergies to Iodine based contrast from an unknown date and unknown if ongoing, sulfonamide allergy from an unknown date and unknown if ongoing. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 28Dec2020 at 12:00 at 41-years-old and experienced no symptoms (first dose; Lot number: EJ1685, EXP: Mar2021, vaccine location: left arm). Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), levocetirizine dihydrochloride (XYZAL), omeprazole (PROTONIX); all taken for an unspecified indication from an unspecified date to an unspecified date; within two weeks of vaccination. On 16Jan2021 at 00:00, the patient experienced: injection site pain 12hrs post injection, intense chills/shivering 12hrs post injection #2. On 16Jan2021 at 03:00, the patient experienced: 15hrs post injection, muscle aches, joint pain. Therapeutic measures were taken as a result of intense chills/shivering 12hrs post injection #2: relieved by 500 mg of paracetamol (TYLENOL) upon onset of chills (as reported). The clinical outcome of the events was recovering (as reported). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

All symtoms were for 45 hours Fever 102 Resting heart rate 125-130 Severe Headache Back Pain Chest pain on inspiration Mild shortness of breath Weakness Loss of appitite

All the following symptoms lasted for 45 hours Fever 102, resting HR 125-130, severe headache, severe back pain, muscle aches, chest pain on inspiration, weakness, mild nausea with loss of appitite.

Fever; Headache; body aches; Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021, at 18:30 as single dose for COVID-19 immunization. Medical history included hyperthyroidism and known allergy to latex. Concomitant medication included St. John's wort (MANUFACTURER UNKNOWN), elderberry (SAMBUCUS NIGRA), cetirizine hydrochloride (ZYRTEC). The patient experienced fever, headache, body aches and sore arm on 15Jan2021, at 04:30. No Covid prior vaccination was noted; the patient has not been tested for COVID post vaccination. No treatment was given for the events. The outcome of events was recovered in Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

"Pfizer-BioTech COVID-19 Vaccine EUA" Received 1st dose of vaccine in left arm at 10:28 a.m. Drove home and at 4:00 p.m. face, forehead, and neck turned bright red, facial tightness, feeling like face was on fire. Heart rate recorded between 112bpm and 115 bpm and began having shortness of breath. Then began feeling nauseous, eyes were itchy and had a headache. Took 10 ml Benedryl @ 4:40 p.m. and drank some water. 7:00 p.m. still have slight facial and neck redness and headache.

245 pm Rash on lower arm 600 chills 700 leg cramps significant to make muscle fasciculations 900 bowel dysfunction Following day, flu like symptoms, chills, aches, etc Rash still has not gone away I have had abdominal cramping and significant pain. It has worsened to resemble the pain I had prior to my hysterectomy and endometriosis ablation/scar tissue removal.

It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.

Saturday morning. Whole body aches and chills. Severe headache all day. Nausea and eventually vomiting twice in the evening. Very exhausted. Tried tylenol, cold packs, hot packs, ginger ale - none were helpful. Took long hot shower and bath after vomiting and felt a little relief. These symptoms lasted 12 hours or so and then I felt fine besides being exhausted. By Sunday evening I was completely back to normal.

This is a spontaneous report from a contactable consumer. A 41-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) on her left arm, via an unspecified route of administration on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included spironolactone, loratadine (CLARITIN) and fish oil. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (first dose). The patient experienced severe chills with body shaking for 6 hours, excruciating headache, fever, sore throat, nausea and excessively high resting heart rate (over 100- usually under 60); all on 08Jan2021 20:30. No treatment was received for the events. The outcome of the events was recovered on 09Jan2021 02:30.

Awoke on 1/29/21 with dizziness and fatigue, which interfered with daily functioning and led to some lost time at work. Ibuprofen taken, but no further treatment. Resolved by midday.

Elevated blood pressure, fever, malaise, headache, dizziness, loss of appetite, abdominal pain. all of these symptoms came on gradually and worsened 20 hrs after vaccination. symptoms lasted a full 48hrs for me and slowly dissipated over the following days. Itching at injection site started 72hrs after and has now ceased

Fever and chills, fatigue, body aches, headache, weakness, vomiting, pain at injection site and back pain, joint pain, that started approximately 10 hours post injection and lasted for approximately 36 hours.

Fevers; chills; significant myalgia; fatigue; This is a spontaneous report from a non-contactable physician reported for herself. This 41-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscular at left arm on 15Jan2021 09:30 am at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications were none. The patient previously received fluconazole (DIFLUCAN) experiencing allergies and the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular at left arm on 26Dec2020 03:00 PM at single dose for covid-19 immunisation. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no COVID prior vaccination, no COVID tested post vaccination. The patient experienced fevers, chills, significant myalgia, fatigue on 15Jan2021 at 09:30PM. No treatment was received. Outcome of all events was recovered on Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Starting the day after the injection she began having a fever as high as 102.4, severe chills, joint pain, headache, nausea, vomiting, body aches

Two hours post injection, developed numbness, tingling, extreme cold in hands and feet with fatigue. Slept for 3 hours, awoke feeling better. 14 hours post injection developed severe body aches, chills, fever, numbness in hands and feet, severe abdominal pain and cramping, and a rash on arms and abdomen.

have limited use in my L hand; numbness down the L side of my body into my L foot; experiencing a major flare-up of my condition; low-grade fever (between 99-100); severe muscle & joint pain; severe muscle & joint pain; existing nerve impingement affecting the left (L) side of my body & both sides of my face; decreased concentration & executive functioning; GI upset; anticipated some inflammation response to the vaccine; feel sick; This is a spontaneous report from a contactable other-HCP (patient). A 41-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 30Dec2020 at 18:00 at single dose in right arm for covid-19 immunization. Medical history included Ehlers-Danlos syndrome hypermobility type, IgA deficiency, cervical radiculopathy, spondylosis of cervical region, chronic hypertension, fibromyalgia, androgenic alopecia, seasonal allergies, and known allergies: gold, nickel. The patient's concomitant medications were not reported. The patient previously took prednisone and experienced allergies. The patient reported that she anticipated some inflammation response to the vaccine from 04Jan2021. Briefly, she started to feel sick around 04Jan2021, by 10Jan2021 was experiencing a major flare-up of her condition requiring additional medication and time off from work. She had had a low-grade fever (between 99-100) from 04Jan2021 for 7 days, severe muscle and joint pain from 04Jan2021. She had existing nerve impingement affecting the left (L) side of her body and both sides of her face from 04Jan2021. Beginning 12Jan2021 she had limited use in her L hand, numbness down the L side of her body into her L foot. This was most likely due to significantly increased levels of inflammation as a result of the vaccine. She had also had GI upset, decreased concentration & executive functioning from 04Jan2021. It was unknown if the patient received treatment for the events. The outcome of the events was not resolved. The events resulted in doctor or other healthcare professional office/clinic visit.

red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site; Severe pain from neck to hand, shoulder blade to chest (right side); Severe pain from neck to hand; severe pain from neck to hand, shoulder blade to chest (right side); unable to lift arm above shoulder; second dose received on 12Jan2021; first dose received on 18Dec2020; Chills; fatigue; hive; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), intramuscular (right arm) on 12Jan2021 (14:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: unknown) intramuscular (right arm) on 18Dec2020 for Covid-19 immunization. Medical history included "known allergies". The patient's concomitant medications were unspecified (received in 2 weeks). The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 (pending clarification), the patient experienced chills, fatigue, and hive. On 13Jan2021 (07:00), the patient experienced severe pain from neck to hand, shoulder blade to chest (right side) and unable to lift arm above shoulder, and hive. On 14Jan2021 (pending clarification), the patient experienced red and hot area approximately 2 1/2 X 1 1/2 inches distal to injection site. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. Information on the Batch/Lot number has been requested.

Bad headache that triggered a neuralgia attack; Bad headache that triggered a neuralgia attack; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL8982) via an unspecified route of administration on arm right on 15Jan2021 13:45 at single dose for COVID-19 immunisation. Medical history included occipital and trigeminal neuralgia, C5-C6 cervical cage, temporomandibular joint syndrome (TMJD), cerebrospinal graft. Known allergy: shellfish, walnuts, mustard, sweet potato. Concomitant medication included gabapentin, acetaminophen. The patient previously took penicillin B, phenergan and chloral hydrate (PHENERGAN), Codeine and linalool, all experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 16Jan2021 06:00, the patient woke up with a bad headache that triggered a neuralgia attack. It persisted for 24hrs. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered in Jan2021.

Injection site pain; headache; muscle pain; chills; fever; This is a spontaneous report from a contactable Other HCP reporting for self. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), via an unspecified route of administration on 18Jan2021 09:30 at single dose for COVID-19 immunization. Patient received first dose of bnt162b2 on 31Dec2020. Medical history included Fatty liver and vertigo. The patient's concomitant medications were not reported. Patient had allergies medications. The patient experienced Injection site pain, headaches, muscle pain, chills, fever on 18Jan2021 16:00. Outcome of events was recovering.

high platelets; fatigue; sharp muscle pains in hands and elbows; Headaches; nausea; Canker sore on my tongue; had a sizable bruise; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Jan2021 11:45 AM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient is not pregnant. Patient previously took the first dose of BNT162B2 at single dose for COVID-19 immunization. Patient have had a lot of fatigue, sharp muscle pains in hands and elbows at day 9 post injection (17Jan2021). Patient was now developing a Canker sore on her tongue as a fellow coworker had the same reaction (Jan2021). Patient have high platelets and have had a sizable bruise for 9 days. Headaches and nausea were present at three hours post injection (09Jan2021). AE resulted in doctor or other healthcare professional office/clinic visit. No COVID prior vaccination. No COVID tested post vaccination. covid test type post vaccination included Nasal Swab on 12Jan2021 with test result of Negative. No treatment received for the events. Outcome of the events was unknown. Information on the Lot/batch number has been requested.

Fever; body aches; headache; fatigue; arm soreness; This is a spontaneous report from a contactable nurse, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 20Jan2021 at 06:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162B2 (at the age of 41-years-old; Lot Number: EJ1685) on 30Dec2020 at 06:00 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination except the first dose of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 20Jan2021 at 19:00, the patient experienced fever, body aches, headache, fatigue, and arm soreness. The patient was not treated for the events. The clinical outcomes of fever, body aches, headache, fatigue, and arm soreness, were not recovered.

Pt. stated that she received the COVID vaccine on 1/20/21. On 1/21/21 she felt tired, had loss of appetite. She reported that she went to a store, and apparently "passed out." Employees of the store told her that she had a seizure. Pt. was transported to local ER, where she states that she had a CT of brain, blood work and was told "everything is normal." Stated that she had COVID testing both in the ER and at work, both reportedly negative. This clinic, has thus far been unable to obtain the individuals medical records from the ER. When seen in our clinic on 2/3/21, pt. stated that she is feeling better, but fatigued. No other loss of consciousness reported by pt.

Woke up 7:15 am with Headache, chills, fever of101.4, body aches, joint pains, fatigue and on/off chest pain. Body aches and fever/chills resolved by 1pm and chest pains/joint pains and fatigue and on/off chest pains continued longer Treatment bed rest/Ibuprofen 600 mg x 2 doses

fever (highest 100.8), severe muscle pain, joint pain, jaundice (I have Gilbert's sydrome), axillary and cervical lymphadenopathy on L side, headache, restless leg, nightmares

typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/The spot was raised and turned bright red; typical site reaction at the time of injection/my arm was sore; I felt lethargic; hot to the touch; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231) intramuscular on 08Jan2021 10:30 AM at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included unknown allergies(reported as "Known allergies: yes"). There were no other medical history. No COVID prior vaccination. Concomitant medications (Other medications in two weeks) included ibuprofen (ADVIL [IBUPROFEN]), fexofenadine hydrochloride (ALLEGRA 24 HOUR), diphenhydramine hydrochloride (BENADRYL) and montelukast sodium (SINGULAIR). No other vaccine in four weeks. Facility type vaccine is Hospital. The patient had a typical site reaction at the time of injection on 16Jan2021 09:00 AM. The spot was raised and turned bright red, and her arm was sore. The patient felt lethargic. After a few days those symptoms went away. The spot on her arm disappeared. Eight days later, the spot on her arm reappeared. It was bigger, bright red, and hot to the touch. Patient's arm felt sore again and she had lethargy again. A doctor confirmed it was not cellulitis. No treatment was given for the events. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested for COVID-19 since the vaccination. Outcome of the events was recovering (as reported).

Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid based on the known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Soreness of arm ,The following day I woke up and felt fine and cup of coffer I felt nauseated , headache, Took Advil and headache was worse.. The following day I still had a really bad headache and felt nauseated .

Symptoms - ?Patient reports around 04:00 while at work began with back pain, chills. Patient reports she took Tylenol at 0400. Patient reports after her shift went home and went to bed and when she woke up around 11:00 am took her temperature at fever Tmax 101.6 and took Tylenol at 11:00 am. Patient reports + congestion but endorses she has hx of asthma and allergies and takes Zyrtec daily. Patient denies COVID-19 exposure and travel. Last day of work and shift - ?2/4/21 Home remedies? - Tylenol at 11:00 and rest Any improvement? ? mild improvement Recommendation? Patient educated to continue to monitor symptoms at home and to take Tylenol and motrin as directed in the Medical Directive and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Workplace Policy. Patient verbalized back understanding and denied further questions at this time. Patient educated to contact vaccine support line if worsening of symptoms, Patient verbalized back understanding.

Temporary nausea, significant fatigue, Muscle pain, Joint pain Redness, pain and swelling still remains at site of injection Pain on top of head, but not necessarily a fullbown headache

experienced a bad headache; had arm pain in the vaccinated arm (left), only when lifting my arm; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:00, at single dose, for COVID-19 immunization, at workplace clinic. There were no medical history and no allergies to medication, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin c, colecalciferol (VITAMIN D), vitamin b and ibuprofen (ADVIL). The patient did not receive other vaccines within 4 weeks prior to BNT162B2 vaccine. On 20Jan2021 at 08:00, the patient had a bad headache and had arm pain in the vaccinated arm (left), only when lifting her arm. The headache went away during the evening without treatment. The patient did not take any pain relief medication. No treatment was given for the events. The patient recovered from headache on the evening of 20Jan2021 and recovered from "had arm pain in the vaccinated arm (left), only when lifting my arm" on an unspecified date. The events were assessed as non-serious. No follow-up attempts are possible. No further information is expected.

moderate intensity myalgias and arthralgias; moderate intensity myalgias and arthralgias; fatigue; headache; I have been having difficulty with routine activities due to pain; I have been having difficulty with routine activities due to pain; pain at the lumbosacral area; ESR elevated; ANA is positive; This is a spontaneous report from a contactable physician (patient). A 41-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL1283), on 05Jan2021 at single dose in left arm for COVID-19 immunisation at hospital. Medical history included rhinitis allergic and eczema. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and ethinylestradiol, norgestimate (TRINESSA). The patient previously took ciprofloxacin hydrochloride (SPECTRA) and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EH9899) on 16Dec2020 at 09:00 for COVID-19 immunisation in the left arm and experienced myalgia, arthralgia, fatigue and headache. After the second dose on unspecified date in Jan2021 the patient developed moderate intensity myalgias and arthralgias, also significant fatigue and headache. The patient waited the 2-3 days after vaccination to see if adverse reaction improved, and it improved at the third day, but unfortunately the same symptoms started again one week after second dose of vaccine and have no improved. The patient had symmetric polyarthralgias affecting her hands, wrist, knees, ankles. She had been having difficulty with routine activities due to pain. Also pain at the lumbosacral area. Also have myalgias and fatigue affecting her work and routine activities. The patient also had a mild HA. The patient underwent laboratories after symptoms began again and CBC, CMP, CK, RF, Anti-CCP and TSH are WNL. But, ANA was positive which in the past was negative and have a ESR borderline elevated for her age. The patient was going to see a rheumatologist, but all this that she was feeling coincides with the vaccination for COVID 19. The outcome of the events was not recovered, no treatment was performed.

moderate intensity myalgias and arthralgias; moderate intensity myalgias and arthralgias; fatigue; headache; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EH9899), via an unspecified route of administration on the left arm on 16Dec2020 09:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included rhinitis allergic from an unknown date and unknown if ongoing, eczema from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ethinylestradiol, norgestimate (TRINESSA). The patient previously took septra and experienced drug hypersensitivity. After the first dose of the COVID 19 vaccine, on 16Dec2020 20:00 the patient developed moderate intensity myalgias and arthralgias, also significant fatigue and headache. She waited the 2-3 days after vaccination to see if adverse reaction improved and for the first dose it improved at the third day but unfortunately the same symptoms started again one week after second dose of vaccine and have no improved. No treatment was received for the events. The outcome of the event was not recovered.

pt states that she started running fever 99.8 with chills, headache, body aches, vomiting and diarrhea later on the day of the vax. Next day she only had body aches. She stated that today 2/5/2021 she has body aches, headache and dizziness. Pt has not contacted her PCP at this time.

resurgence of Covid-19 symptoms experienced the month prior; I still feel sick; congestion; sore throat; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231) on 08Jan2021 17:00 at single dose in left arm for Covid 19. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included sleep, had Covid back in Dec, early Dec. Concomitant medication within 2 weeks of vaccination included zolpidem tartrate (AMBIEN) to sleep. The patient experienced resurgence of Covid-19 symptoms experienced the month prior on 11Jan2021 12:00 AM. She had her first dose on 08Jan2021 and all of her Covid symptoms return except this time little bit worse than the first. It says 13 days since her dose and she still feel sick on 11Jan2021 12:00 AM, congestion on 9Jan2021, sore throat on 9Jan2021. No treatment received for all the events. All the events result in Doctor or other healthcare professional office/clinic visit. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. The outcome was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated, "Advil, probably 400 mg maybe like two times a day at most but it wasn't every day. I did not take it every day, I take it for couple of days."; Sender's Comments: The 41-year-old female patient had Covid in early Dec2020. On 08Jan2021, she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and experienced resurgence of Covid-19 symptoms on 11Jan2021. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the resurgence of Covid-19 symptoms most likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

sore arm within 4hrs; fatigue; joint pain; fever; This is a spontaneous report from a contactable healthcare professional (patient). A 41-year-old female received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3302) at left arm 08:30AM on 20Jan2021 for Covid-19 immunization. The patient had first shot 08:00AM on 30Dec2020 at right arm and experienced sore arm within 12hrs, fatigue, joint pain, skin itch, and enlarged right supraclavicular lymph node. The patient had no known allergies and other medical history was not reported. Concomitant medications included metformin. The patient experienced sore arm within 4hrs, fatigue, joint pain, fever around 12:15PM on 20Jan2021. No treatment received for the events. The patient had no Covid prior vaccination and not Covid tested post vaccination. The event did not resolve at the time of reporting.

After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.

Within ten mins, had a flare of pots and vestibular issues i e. Tachycardia, dizziness, ataxia, headache, tremors in neck overall difficulty with balance. Have had similar symptoms with antibiotic use.

I immediately felt nauseated and fatigued, but severe reaction occurred at 10 pm. Extreme weakness and tingling on lips and tongue with difficulty breathing. Migraine and body aches not resolved with OTC meds. Lower back pain was notable and prevented me from sleeping. I passed out in the bathroom when trying to get Tylenol.

dizziness within first 20 min of administration resting heart rate in the 100's all night while trying to go to sleep. Started about 30 min after vaccination and lasted 5-6 hours. extreme exhaustion headache

At 3pm the day I received the shot I was woken up from a nap with intense tooth pain. My top, front 4 teeth were in so much pain I cried. I took 100mg of Tylenol and the pain lessened in about 2 hours. At approximately 10am on 2/5/21, I became clammy with shivers yet I was feeling over heated. My temperature was 99.3 degrees. I did not take any medicine but instead took a nap. When I woke up, my temperature felt normal. I did feel dizzy until around 4:3pm that same day. I still get headaches in the front of my forehead since 2/5/21.

Fatigue; dizziness; weakness; increased heart rate; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 20Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home/Senior Living Facility. Patient age at vaccination was 41 Years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia, Hashimoto's Thyroditis, allergy to Penicillin. Concomitant medications included ibuprofen (IBUPROF), loratadine (CLARITIN), sambucus nigra extract (SAMBUCOL), fluticasone propionate (FLONASE), and multivitamin. On 21Jan2021 the patient experienced fatigue, dizziness, weakness, increased heart rate, all reported as non serious. No treatment was received for the events. The events had not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.

Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.

Heaviness in chest; Racing heartbeat; Fatigue; This is a spontaneous report from a contactable other hcp (patient). The 41-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Jan2021 10:15 in Left arm at single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks, no other medications in two weeks, increased protein. No covid prior vaccination. No covid tested post vaccination. No Known allergies. The patient's concomitant medications were not reported. The patient experienced Heaviness in chest, racing heartbeat, fatigue on 22Jan2021. No treatment received. The outcome of the events was not recovered. No follow-up attempts are possible, information on batch number cannot be obtained.

Light headedness; scratchy voice; itchy eyes and throat; itchy eyes and throat; pink and hot swollen circular hive/welt underneath injection site on left arm; pink and hot swollen circular hive/welt underneath injection site on left arm; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 07:30 (at the age of 41 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included seasonal allergies from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination, but did receive the first dose of BNT162B2, on 31Dec2020 in the left arm. On 21Jan2021 at 09:30, the patient experienced light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm. The patient did not receive treatment for the events. The clinical outcome of light headedness, scratchy voice, itchy eyes and throat, pink and hot swollen circular hive/welt underneath injection site on left arm was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.

a lot of body aches; headache; some shortness of breath; This is a spontaneous report from a contactable Other Health Professional (HCP) reported for herself. A 41-year-old female patient (pregnant: no) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 18Jan2021 at 12:15 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 41 years old on 28Dec2020 for COVID-19 immunisation (first dose, via intramuscular, administration time=10:00 AM, vaccine location=Left arm). After the second vaccine starting about 10 hours after it was given, the patient had a lot of body aches, headache, and some shortness of breath on 19Jan2021. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No other medications in two weeks. The outcome of the events was recovered on an unspecified date. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021067674 maternal, infant cases;US-PFIZER INC-2021068772 maternal, infant cases

heart started beating fast; lumps grow up on my arm; short of breath; kind of weak; uncomfortable feeling; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse (patient) reported a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via unspecified route on right deltoid single dose for COVID-19 immunization on 03Jan2021, at 41-year-old. No medical history. Concomitant medication was reported but unspecified. After the patient had received the shot (Jan2021), her heart started beating fast, felt lumps grow up on her arm and became little short of breath. That went away rather quickly, about within 3 hours and the patient was still kind of weak and just uncomfortable feeling. Action taken for BNT162B2 was not applicable. Outcome of the events heart started beating fast, lumps grow up on her arm, short of breath was resolved in Jan2021; outcome of the other events was unknown. Causality assessment per the reporter was checked as yes.

Became extremely confused and felt a pressure on my chest. Was not going away after 30 minutes. Vitals were erratic but within normal perimeters. Was sent to the ED to monitor. The second day was washed out and felt sick but nothing else was needed.

Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Went to get the vaccine, sat down and received it in her left arm, and while waiting for the 15 minutes and after 10 minutes she stood up and coughed, a nurse came to her and asked if she could help her, she grabbed her throat and told her she could not breathe. She gave her an Epi-pen shot in her right thigh and then she put oxygenation on her finger, around 5 minutes later they took her to the ER. She felt fine immediately after the. The nurse then gave her an IV but they did not give her any medicine. She also had her BP monitored and checked her vitals signs, and a doctor talked to her and kept her for an hour for monitoring, and then released from the ER.

trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report from a contactable consumer who reported for herself . This 41-years-old no pregnant female patient received first dose of bnt162b2 (BNT162B2) from LOT# E19262, on 03Feb2021 17:30 on right arm at SINGLE DOSE for covid-19 immunisation .Age at vaccination:41 years. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine . The patient received other medications within 2 weeks of vaccination .Medical history included :Allergy to adhesive, ADHD, high blood pressure (HBP), depression, anxiety, gerd. On 04Feb2021 20:00 the patient experienced chills, urge to cry, trouble lifting in arm , pain in arm and she was Nauseous. Events reported as non serious .No treatment received. Outcome was not recovered. Prior to vaccination the patient was not diagnosed with COVID-19Since the vaccination, the patient has not been tested for COVID-19

Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.

deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours

Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.

Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.

Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)

Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.

Chills, rigors & low-grade fever, lasted about 24 hrs. Took Tylenol & Ibuprofen for symptom relief. Developed irregular shaped red spots on hands & feet. They come & go, sometimes they itch or hurt. These spots come & go most days since receiving the vaccination. When they itch, rub Benadryl cream which stop the itching.

About 5 minutes after receiving the shot, I experienced a tickle in my mouth, and then shooting burning waves down both sides of my spine (just to the left and right) starting in my neck and settling in my groin. It felt like intense burning and buzzing waves going down from my neck. The paramedics came, said there were no signs of anaphylaxis, and took me to ER. They gave me benedryl and pepcid in an IV, I felt drowsy. The waves eventually subsided and were gone around the time of the benedryl (not sure if before or after).

After the shot, I only had a slightly sore arm. Several hours later, after I had fallen asleep, I awoke to sudden onset face swelling on my right side, severe and sudden sneezing and stuffiness, and a severe asthma attack. We called 911, and in the meantime I took 2 Benadryl and used my rescue inhaler. My breathing was assessed as diminished by the paramedics, and I was taken to the hospital. I was given oxygen and prednisone, and monitored. About 2 hours later I was released.

On 1/12/2021 around 2 am I started feeling, chills, body aches, headaches, diarrhea & fatigue. They lasted 50 48-72 hours. I took Tylenol for my symptoms. I did have Covid-19 on May 2020.

Prolonged joint pain in hips, knees, ankles and feet. In the last month, I have only had 4 days of no pain. I did not have joint pain before getting the second dose of the COVID-19 vaccine. Approximately 12 1/2 hours after receiving the vaccine, I ran a low grade temp of 99.9, had chills, rigors, aching, and joint pain. Fever went away the next day. Joint pain remained.

12 hours post dose 2 covid vaccine, patient had high heart rate to 160 and temp of 101 and diaphoresis

Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.

Within 45 mins of the first injection I felt dizzy and not myself. That night I had severe fatigue, body aches, chills, and headache. I woke the following day with severe fatigue, headache and tachycardia. Five days out I had muscle twitching and lymphadenopathy. I had tachycardia with heart rate in 120-130s at rest and higher with exertion. I had sustained tachycardia for a solid two days and then intermittently for five days.

Day of vaccine 2/20 to following day experienced injection site pain but no other symptoms. The night of 2/25 (almost 6 days later) experienced flu like symptoms - chills, shaking due to cold, fever, thirst, joint and body aches, light headedness, fatigue. Morning of 2/26 chills and fever had subsided, had 8/10 severity headache that gradually decreased throughout the day. Body aches gradually subsided throughout the day and all symptoms were resolved by 6pm on 2/26. I had very similar symptoms after my first dose as well - initial injection 1/29 at 12:30pm, flu like symptoms began early morning of 2/1 that lasted about 15 hours.

W/in 5 min I began experiencing itchiness of the face and nose, half fever style. Because of poor time planning on the county's part, I wasn't able to stay fir observation. By the time I drove 20 min home, the itch had spread to the most sensitive (eczema prone) regions and was all over my body within an hour. I took 4 benadryl, 1 every 2 hrs, for the rest of the evening. Slept 13 hrs through night, didn't need another benadryl until after showering. Itch continues but at a much lower level.

Numbness in tongue and lips six hours after taking the vaccine. I took a Benadryl and the symptoms subsided after 60 minutes. I also experienced dizziness and weakness right after taking the vaccine, which lasted for 24 hours. Other symptoms include tiredness, headache, muscle pain, chills, low-grade fever, and nausea, which have lasted for 24 hours and continue now.

Friday at 4pm I experience severe unquenchable thirst and mild injection site soreness. Saturday morning was restless sleep and headache with severe joint pain and thirst. All Saturday same. Skin hurt to touch and knees and finger knuckles hurt to touch. Vomiting. Throbbing injection arm pain and the urge to constantly stretch all limbs. Sunday all subsided except the throbbing arm pain. Sunday evening at 8 pm throbbing arm worse and headache. Monday 3am restless sleep and miserable comfortableness. Throbbing arm and restless painful shockwaves through entire body. Skin severely hurt to touch. Went to the ER. Treated with Atavan and prescription Motrin.

Headache daily in the morning. On 2/26/21 developed a migraine with vomiting and went to ER. Today on 3/1/21 continues to have headache every morning but not as severe and today has had 3 loose, watery stools.

MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

fever (102.3), sore arm, sore arm pits, headache, brain fog, chills, body ache, food aversion, nausea, fatigue

the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included High Blood Pressure. Concomitant medication included amlodipine for High Blood Pressure. The patient previously took first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization and experienced "gum on my right face was swollen". It was reported that patient received the second dose and when she woke up, she had headache and then noticed the gums were swollen but not as big as the first time in Jan2021. No treatment received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.

Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 24Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included valaciclovir hydrochloride (VALTREX). The patient previously took acetylsalicylic acid (ASPIRIN) and hydrocododone and experienced allergies. The patient experienced cold chills and aches, extreme fatigue, loss of appetite on 26Jan2021 10:00 AM. At days 5-7, my symptoms went from to strongly moderate. Fever last night (30Jan2021) of 102.3. No treatment was received for the events. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room

Shakes, chills, mild temperature (100), insomnia, nausea, exhausted, weak. Entire left side hurt, lymph node under arm - near breast on side of vaccination swollen for 4 days. Headache Onset of chills began at 1am. Around 5am I started shaking and nauseous and I had not been able to fall back to sleep. 5am 2/25 until I woke up for the day 2/26 at 6am, I had the nausea, chills, weak. Lymph node swollen stayed for 4 days. I felt very confused, like I couldn't hold a full thought. No reaction to 1st vaccine except a sore arm

face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.

flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.

headache; on and off chills; lethargic; nasal congestion; started feeling run down; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received 2nd dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 16Feb2021 12:00 at single dose for covid-19 immunisation. Medical history included nocturnal seizures, hypothyroid, sinus infections, seasonal allergies, allergies to sulfa drugs. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine, glucosamine, naproxen sodium (ALEVE), cetirizine hydrochloride (ZYRTEC). The patient previously received 1st dose of bnt162b2 on 26Jan2021 at 11:00 in left arm for covid-19 immunisation. At about 11 pm after the vaccination (16Feb2021 23:00), started feeling run down. Woke up the next morning (17Feb2021) with headache, on and off chills, lethargic, with nasal congestion. No treatment received in response to the events. The outcome of events was recovering. This case was reported as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

I just wanted to report extreme PHYSICAL EXHAUSTION. The first day it felt like someone had drugged me with a full body sedative but my brain function was fine. Since then, I've only had a low grade temperature 98.4 (I normally have a much lower temp - 96.5/97) but my whole body feels so heavy - my legs and arms feel heavy to lift or to walk. I just wanted to report this in case it can help anyone understand more about the vaccine. I'm 4 days in and it hasn't gone away so I figured it was worth mentioning. The strange part being that I have no real fever to go along with the extreme physical exhaustion, which is strange right? I started taking some Tylenol but otherwise just hydrating and trying to go for a walk every day.

Patient developed headaches and night sweats the day following the second vaccine administration and symptoms still persisting one month later.

Pt developed a few hive-like lesions on her legs on 1/28/2021, 2 days following first COVID vaccination. Over the next 2 days developed more. Each lasted less than 24 hrs, but some lesions were always present. No other symptoms. Allegra resolved hives. On 1/17/2021 after second COVID vaccination, she developed headache, body aches, and low grade fever lasting 1 day. Three days later, hives returned, worse than with first vaccination. Allegra resumed up to qid. On 2/23/2021 developed severe chest pain, waxed and waned through night, resolved by next morning. Was hive-free between 2/24 and 2/28 when the hives recurred. Has had two bouts of lip swelling. Hives persist, despite antihistamine use, to the present.

With having MS, I have severe anxiety and I was anxious before going in- numbness and tingling in my legs and tingling on my tongue. Took Benadryl - tongue tingling went away and the legs tingling and numbness was the same and started getting worse - they monitored my vitals and everything looked good and numbness remained. I had a driver and they allowed me to leave due to the Benadryl _ just took that one dose of Benadryl (didn't take anymore after that) and then the numbness in my legs remained for about two and a half weeks. I used a cane for two days. I had a fever and chills that first night, body aches and injection site pain and severe fatigue and those symptoms lasted one day except fatigue was for three days. The day after the shot was the worse of the symptoms. They followed up with me that evening and they followed up with me at work. I had the next dose - February 4, 2021 and experienced everything except the numbness in the tongue. Informal doctor visit because I work there.

headache was heavy; her body and bones felt tired; sinuses felt heavy; shoulders are heavy; her thigh on the back is heavy; stated that she cannot move but can walk; neck on side when she has hiccups that she feels pain and in her back; neck on side when she has hiccups that she feels pain and in her back; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On the second day (Jan2021), her body and bones felt tired when she stretched and her sinuses felt heavy. On 01Feb2021, her headache was heavy. She took Benadryl. Her shoulders, neck on side and her thigh on the back were heavy on 2021. She cannot move but can walk on 2021. When she walks that it feels likes electricity. Also on 2021, her neck on side when she has hiccups that she feels pain and in her back. Patient was worried about it and wanted to know if it was normal to feel like this after the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Progress Notes (Nurse Practitioner) Pt called to follow up s/p covid-19 vaccine done on 02/24/21. She reports she took a nap yesterday after getting home and felt better afterwards. Today she feels well. Denies any other questions or concerns. She is appreciative of the phone call. Progress Notes at 2/28/2021 7:34 AM Expand AllCollapse All VACCINE CLINIC 2/24/2021 Subjective Patient is a 41 y.o. female who was seen at SVH COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, headache, nausea, tingling lips and a metallic taste in her mouth. She denied rash, difficulty breathing, difficulty swallowing, throat tightness, facial swelling and lip swelling. She does mention having a history of anxiety and did take her duloxetine and Wellbutrin today. Denies use of her Ativan recently. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms, respiratory distress, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness and headaches Patient denies chills, facial swelling, chest tightness, shortness of breath and wheezing +nausea and metallic taste in mouth: Previous Reactions: Denies Objective Vitals Vitals: 02/24/21 1427 02/24/21 1434 BP: 126/70 112/68 Pulse: 81 80 SpO2: 99% 96% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: Tylenol and water Follow up response to treatment: good. She noted some lightheadedness prior to discharge but other symptoms were improved. I walked patient around the bay area and she was feeling okay. Her vitals were stable. Pt was escorted out of the facility. Patient discharge: Stable to go home and follow up with PCP. Electronically Signed 2/24/2021 2:43 PM

Fatigue; severe chills; slight fever; received second dose of bnt162b2 on 04Feb202; received the first dose of bnt162b2 on 12Jan2021; This is a spontaneous report from a contactable other health professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, on 04Feb2021 13:30 at SINGLE DOSE for covid-19 immunization. Medical history included IgA nephropathy, chronic kidney disease, hypertension, familial hyperlipidemia and pre diabetes/metabolic syndrome. The patient received the first dose of bnt162b2 on 12Jan2021 at 14:15 in the left arm, covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included losartan and labetalol, both from an unspecified date for an unknown indication. On 05Feb2021 07:15, the patient experienced fatigue, severe chills and slight fever. The outcome of events fatigue, severe chills and slight fever was recovering. Outcome of the other event was unknown. Follow-up attempts are completed. The information on the batch/lot number has been obtained.

Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.

Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021

body chills; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 09Feb2021 at 41-years-old at a single dose for COVID-19 immunization; administered in a nursing home (workplace). The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 19Jan2021. On 10Feb2021, the patient experienced body chills (non-serious); with no treatment received. The clinical outcome of the event was not recovered.

sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

started feeling tired/she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after; fainted/blacked out right after; she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 41-year-old female patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 16Mar2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization . There were no patient's medical history and concomitant medications. The patient waited the 15 minutes at the site and felt fine. She got on the road at 6pm and started feeling tired. She was on the phone with her parents and mentioned she was starting to feel tired, then really tired and the mom said 'maybe you should pull over' and she didn't have time to process it as she fainted/blacked out right after. When she woke up, she was still behind the wheel the drivers steering wheel airbag and airbag at her legs had deployed. She has no memory of what happened but her daughter (age 9) was in the back seat of the car with the dog. The patient's daughter said that she accelerated into the intersection passed through ("I blacked out as the light was changing to green") she rear ended another car and then drove around that car and she think the car stopped itself possibly not sure but when she awoke she was directly in front of the vehicle she had rear ended. The driver in the other car was taken in an ambulance with she believes the other driver had some discomfort in the neck/back but she was not 100% sure. It was reported that the outcome of events was recovering. It was unknown if the patient receive treatment for the events. The events were considered as serious due to hospitalization. Information on the lot/batch number has been requested.

a prolonged episode of her fibromyalgia and Sjogren's condition; a prolonged episode of her fibromyalgia and Sjogren's condition; right ankle became swollen; a prolonged episode of her fibromyalgia and Sjogren's condition; joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes); migraines; fatigue; multiple naps throughout the day; brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 41 Years, at single dose on 17Mar2021 (Lot number EN6207) for COVID-19 immunisation. Medical history included fibromyalgia, Sjogrens syndrome and lactose intolerant. Concomitant medications included gabapentin, ciclosporin (RESTASIS), cevimeline all taken for an unspecified indication and start and stop date were not reported. The patient previously took celecoxib and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that her joint pain (which included my neck, my spine, my shoulder, elbows, hands, knees, ankles, feet and toes) was at a 5. Usually, her joint was at a 2. Her right ankle became swollen. Usually, her ankles didn't swell. She also had four migraines during this time - she typically had migraines every two to three months. She experienced fatigue which caused me to take multiple naps throughout the day. She experienced multiple days of brain fog, lasting up to 5 days at a time. Typically, she had brain fog for 2-3 days. Basically, the patient felt like she was having a prolonged episode of her fibromyalgia and Sjogren's condition. The symptoms were still persisting. The patient reported above events was non-serious. It was reported that the adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". And she received treatments for the adverse events including ace bandage for ankles and further monitoring. The patient was not diagnosed with COVID-19 prior to vaccination and she did not test for COVID-19 since the vaccination. Events outcome was not recovered.

delirious; wheezing; fever up to 102.7; shortness of breath; coughing; slurring; body and face were swollen all over; body and face were swollen all over; new onset of widespread bodily pain; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; bad flare of ME/CFS symptoms for about 7 days; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the right arm on 10Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization. Medical history included hypersensitivity to iodine contrast, anaphylactic reaction, hypermobile Ehlers-Danlos Syndrome, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) being evaluated for mast cell activation syndrome. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), montelukast, estrogens esterified/ methyltestosterone (ESTROGEN/METHYLTES), and other unspecified medication. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 10Mar2021 at 14:00 the patient experienced a fever up to 102.7, extreme shortness of breath on standing, coughing and wheezing, delirious and slurring, body and face were swollen all over. The patient called the doctor on call at her primary care physicians office and treated the symptoms with diphenhydramine (BENADRYL), paracetamol (TYLENOL) and mast cell stabilizers. The patient had a bad flare of ME/CFS symptoms, in Mar2021, for about 7 days. She also experienced a new onset of widespread bodily pain in Mar2021 which didn't go away until the second vaccination. The patient received the second dose of BNT162B2 (Lot: ER8730) in the left arm on 31Mar2021 and had a better experience. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of delirious, wheezing, fever up to 102.7, shortness of breath, coughing, slurring, body and face were swollen all over was resolved with sequel on Mar2021; pain was resolved on 31Mar2021; bad flare of ME/CFS symptoms for about 7 days was unknown.

Nausea, severe rashes (hives) red and burning and itchy throughout the body, second high fever that went up to 102.1 followed by chills and body ache, light headed ness and headache. Rashes occurred 10-12hrs after vaccine and got worse till was treated at a medical clinic and er. Had heavy heart rate of 120+ IV administered with diphenhydramine which is continued even now as slight rashes still exists and prednisone was given on Sunday April 19 2021 at 11:50am Later since rashes still persisted was advised by the urgent clinic to go to ER where hydroxyzine was given

- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes -After than, body aches, nausea, arm pain and tiredness -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS

Chills, headache, body aches, nausea, soreness at injection site, heat at injection site, redness at injection site

Tongue felt like it was swelling; Itching; Tickle in her throat; This is a spontaneous report from a contactable pharmacist. A 41-year-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN3518), via intramuscular route of administration in left arm on 02Feb2021 at 11:45 AM at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El1283), via intramuscular route of administration in left arm on 01Jan2021 at single dose for COVID-19 immunization and had no problem post 1st dose. Medical history and concomitant medications were not reported. The patient was allergic to shellfish anaphylaxis. On 02Feb2021 at 12:15 PM, the patient experienced tongue felt like it was swelling, tickle in her throat and itching. During observation period post second dose patient began itching and felt like she had a tickle in her throat. Patient began clearing her throat and asked for some water. RN noted she was rubbing throat and gave her water and benadryl 25 mg PO for itching. Patient noted that her throat was starting to feel funny like it might be closing up and her tongue felt like it was swelling. Epinephrine 0.3mg IM administered immediately after identifying these symptoms and patient wheeled down to ER for evaluation. Patient received IV benadryl in ER and famotidine. Observed for a couple of hours and then released. The outcome of the events was unknown.; Sender's Comments: A causal relationship between BNT162B2 and the reported events swollen tongue, pruritus and throat irritation cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .

Fainting; Nausea; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EW0162) via unspecified route of administration on arm left at a single dose on 08Apr2021 17:00 for COVID-19 immunization. The patient medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Apr2021 at 17:15 patient experienced nausea, fainting, dizziness and fatigue. The outcome of the events was recovered on an unspecified 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.

asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.

@ 1525 Pt stated to this nurse that her throat felt like it was "burning a little". Denies s/s of any breathing issues. Water was given to her by this nurse. @ 1528 she stated that it felt more like "an itchy feeling in her throat/chest". Expressed to this nurse around 1533 that the issues had slightly resolved, and that she felt anxious upon receiving the vaccine. This nurse gave Pt a Benadryl 25mg @ 1539. States that her s/s are better. Pt states she takes the following medications, Allegra po once daily, Flonase daily, and Flovent. Does voice that she has chronic allergies/asthma. Pt is still in observation @ present time 1552. Left observation @ 1554, states that her s/s had improved.

Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site

pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.

After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o "tonsil swelling"....

Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.

After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.

Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)

Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.

Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.

About 16 hours after receiving my second dose of the covid vaccine I began to have chills, muscle aches, headache and fever of 100.8.

About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.

About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.

Flu like symptoms that began the day after vaccination, lasting for 1 day. Reported severe residual joint aches in shoulder, scapula, hips, wrists, ankles. Right sided pain persisted, left side lessened. Relieved by NSAIDS

Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 40 minutes after vaccine was administered

I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node the size of a golf ball at the base of the right side of my neck that lasted for 2 days, I was put on ogmentin for 5 days and it went away after that

Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.

Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg given PO, cough worsening. 1122 second dose of Benadryl given, called for MD. Brought pt to Private room via wheelchair. Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126. IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy. 1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given. Lungs clear. 1140 Coughing stopped, pt able to speak now. Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105 1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114

Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.

Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.

arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision

throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.

she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.

vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.

Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called "tantrum moodiness". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve."

Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique

I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.

Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain. Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally. All other symptoms continued as well.

1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.

3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.

After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.

Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.

Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.

Headache Fatigue Narrative: 24 hours after vaccine administration onset of headache, malaise, feeling poorly - subsequently missed work 12/22 in order to rest; resolved by 12/23

Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.

I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the area and has spread a tiny bit and it's warm to the touch with a hard bump. No other symptoms, except tired. no fever ect

I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a headache and full body muscles aches. I checked my temperature at 7am and it was 100.5 oral. I could barely get out of bed all day. My temperature peaked at 101 despite taking 400mg of Ibuprofen at 9am. It is currently 8 pm on 1/8/20 and I still have a fever, muscle aches, headache and fatigue.

ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.

ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.

ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.

Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.

When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed through and worked the whole shift. I was off due to the holidays for some days but symptoms did not improve. I had the vertigo and nausea for 11 days and on day 7 it prompted me to seek medical care at the clinic. The headache lasted only 2 days.

When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the vertigo was the debilitation factor. I went to work because it was too late to call in sick, I managed to stay the whole day and then I was off some days due to the holidays. The nausea and vertigo lasted 11 days the headache lasted 2 days. I decided to go to the walk in clinic (day 7 - 12/29) because the vertigo and nausea would not go away. They run bloodwork all normal. They told me to take OTC meclizine. It took the edge off helped a tiny bit. I woke up 01/01 symptom free.

immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to their emergency care area, vitals were monitored. Approx 10mins after this episode, she told them she has had this problem for the last 2 weeks. She denies shortness of Breathe or chest pain. Client was release to a family member. Her husband said she never had any other problems, except the shot made her "tired and achey". She was referred to her PCP for follow up>

whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.

2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.

The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks

Morning after the 2nd dose of vaccine I developed chills, body aches, malaise/fatigue. It lasted approximately 5-6 hours and then started to improve.

Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.

Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscle and joint pain.

Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extreme fatigue. Had to use my inhaler twice, get rest, and plenty of hydration for 24 hours then felt fine.

"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling, and pain in my right shoulder and neck. It steadily progressed, and by the morning of 12/25/20, I had almost no range of motion in my neck and right shoulder, and severe pain in my right shoulder/neck/upper back area (heat/ice/ibuprofen/Aleve/Tylenol offered zero relief) . This lasted for a few days, then steadily improved until I returned to work on 12/28/20, where I had mild-moderate pain and most of my range of motion had returned. I still feel like the muscles in my neck and shoulder are tight, but I?m doing stretching exercises with heat/ice at home and it seems to be working its way out. The other symptoms were expected and mild: fever, muscle/joint aches, fatigue. These symptoms come and go ? I?ve had them since being COVID positive in March/2020. Just to be extra safe, I was swabbed for COVID on the 30th and was negative."

- muscle ache in upper arm and should within first half hour of shot - extreme body aches began that evening; continued throughout the day 1/10; still present morning of 1/11, not as intense - temperature spiked to almost 100 that evening; fluctuated throughout the next day

-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache lasted for 24hrs after, body aches chills decreased w/tylenol. Still decreased appetite until 3rd day fever was down to 99-100 w/tylenol

1st dose 12/19/20 Symptoms 12/20/20 headache, severe body and joint pain, fever 101.0, fatigue lasting about 24hrs. 2nd dose 1/9/21 Symptoms 1/10/21 extreme fatigue, body aches, fever 100.4 duration was approximately 24hrs.

Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and developed a diffused urticarial rash and was sent to ED. She also C/O of difficulty swallowing. Erythema B/L cheeks, Rash diffused B?L chest and behind left ear Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given 11:15, SOLU-MEDROL 125 given at 11:30 13:20 feeling much better and has fontal headache discharged home at 14:20

Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and fatigue. I slept most of the day on Sunday after getting the shot the day before. I never checked my temperature to tell if I had a fever. The night sweats continued into sunday night. I took 600mg of advil for the body aches and went to bed. When I woke up around 1:00 in the afternoon the body aches were gone and haven't returned. Sunday night I was sweating most of the night and felt over heated until around 11:00 Monday morning. I am always cold, I am the type who wears sweaters in the house all year long. For me to be that hot in the house is very unusual.